S-1

ApprovedSmall molecule

S-1 is one of 446 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Approved.

Indications

139

Total Trials

Active Trials

445

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

AscitesActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Esophageal CancerActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Esophageal AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Colorectal AdenocarcinomaActive, not recruiting

Biliary Tract CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 1

Active, not recruiting

AscitesPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

Esophageal CancerPhase 3

Active, not recruiting

Gastric AdenocarcinomaPhase 2

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Esophageal AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

Colorectal AdenocarcinomaPhase 3

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

S-1

Taiho Oncology, Inc.

Approved

2 2

Trodelvy

Gilead

Preclinical

37 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Prolia

Amgen

Preclinical

14 5

Zolymbus

AbbVie

Preclinical

1 6

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Chirocaine

PPurdue Pharma LP

Preclinical

1 9

Acupan

YYonsei University

Preclinical

1 10

Nubain

AAultman Health Foundation

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Recruiting

Esophageal Adenocarcinoma

NCT05403242

Q4 2026

Phase 2Recruiting

Concurrent Chemoradiotherapy

NCT06341595

Phase 2Recruiting

Phase II

NCT04566380

Q1 2027

Phase 2Not yet recruiting

Pancreatic Cancer

NCT06166589

Q2 2027

Phase 2/3Recruiting

Gastric Cancer

NCT05699655

Phase 3Active, not recruiting

Gastric Cancer

NCT05144854

Clinical

Trials by Indication[1]

Gastric Cancer46 trials

Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer

Recruiting·FFudan University·Phase 2·NCT07194005·30 enrolled

S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer

Unknown status·KKyungpook National University Hospital·Phase 2·NCT01426646·218 enrolled

RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06385873·32 enrolled

Show 43 more trials

A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

Unknown status·RRenJi Hospital·Phase 2·NCT04152889·20 enrolled

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06256328·226 enrolled

Study of S-1 Plus LV for Advanced Gastric Cancer

Completed·SSun Yat-sen University·Phase 2·NCT02090153·39 enrolled

A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT02296658·60 enrolled

Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

Completed·—·Phase 2·NCT00278863·96 enrolled

Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05627414·30 enrolled

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Not yet recruiting·—·Phase 2·NCT06881017·140 enrolled

Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric Cancer

Unknown status·—·Phase 2·NCT02525237·30 enrolled

Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

Suspended·HHokkaido Gastrointestinal Cancer Study Group·Phase 2·NCT00209664·40 enrolled

Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Unknown status·HHarbin Medical University··NCT03237507·110 enrolled

Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

Completed·HHokkaido Gastrointestinal Cancer Study Group·Phase 1/2·NCT00209638·24 enrolled

Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1/2·NCT00072787·41 enrolled

A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

Unknown status·FFudan University·Phase 3·NCT03475615·215 enrolled

Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

Recruiting·FFujian Cancer Hospital·Phase 2/3·NCT05699655·130 enrolled

Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Unknown status·JJinling Hospital, China·Phase 3·NCT02338518·297 enrolled

Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

Completed·—·Phase 2·NCT01824004·46 enrolled

Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis

Enrolling by invitation·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT06487715·42 enrolled

A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Unknown status·—·Phase 2·NCT04062058·82 enrolled

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Recruiting·RRuijin Hospital·Phase 1/2·NCT07025889·55 enrolled

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT06730373·110 enrolled

Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

Completed·JJapan Clinical Cancer Research Organization·Phase 3·NCT00287768·628 enrolled

A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Unknown status·HHebei Medical University·Phase 2·NCT03718624·36 enrolled

Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT00553696·27 enrolled

Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

Completed·SSeoul National University Hospital·Phase 3·NCT02114359·111 enrolled

A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer

Recruiting·—·Phase 1/2·NCT06732856·57 enrolled

Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Unknown status·FFujian Cancer Hospital·Phase 2·NCT03137004·47 enrolled

The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

Completed·QQuan Wang·Phase 2·NCT04694183·37 enrolled

A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

Completed·CChinese Academy of Medical Sciences·Phase 1·NCT01291407·27 enrolled

A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06555471·40 enrolled

Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Recruiting·SSun Yat-sen University·Phase 2·NCT06451211·53 enrolled

Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

Completed·CChinese Academy of Medical Sciences·Phase 2/3·NCT02979691·350 enrolled

Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

Completed· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT00202969·180 enrolled

Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer

Completed·—·Phase 1/2·NCT01783951·63 enrolled

Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer

Not yet recruiting·Zzhoujing·Phase 2·NCT07018063·35 enrolled

The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

Unknown status·—·Phase 2·NCT03007446·20 enrolled

The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

Completed·SShanghai University of Traditional Chinese Medicine·Phase 2/3·NCT03607656·270 enrolled

Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00960349·14 enrolled

Peri-operative Sintilimab in Combination With SOX in Locally Advanced Gastric Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT04982939·210 enrolled

Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Completed·SSun Yat-sen University·Phase 2·NCT02229058·73 enrolled

S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer

Completed·MMin-Hee Ryu·Phase 3·NCT01671449·338 enrolled

Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01388790·40 enrolled

A Phase II Open-Label Study Evaluating the Efficacy and Safety of Zanidatamab Combined With Chemotherapy as Neoadjuvant/Conversion Therapy in Patients With HER2-Positive (IHC 3+ or IHC 2+) Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·ZZhifeng Zhao, PhD·Phase 2·NCT07685704·46 enrolled

A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT05144854·626 enrolled

Pancreatic Cancer19 trials

A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan

Terminated·TTTY Biopharm·Phase 2·NCT04070313·36 enrolled

Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer

Unknown status·—·Phase 2·NCT03662035·30 enrolled

Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06166589·19 enrolled

Show 16 more trials

Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer

Completed·JJapan Adjuvant Study Group of Pancreatic Cancer·Phase 2·NCT02459652·57 enrolled

Efficacy and Safety of Paclitaxel Liposome and S-1 as First-line Therapy in \ Advanced Pancreatic Cancer Patients

Unknown status·FFudan University·Phase 4·NCT04217096·40 enrolled

A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )

Unknown status·YYanqiao Zhang·Phase 2·NCT03825328·30 enrolled

Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen

Unknown status·FFudan University·Phase 2·NCT04101929·126 enrolled

Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis

Unknown status·FFudan University·Phase 2·NCT02634502·30 enrolled

SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

Completed·NNational Health Research Institutes, Taiwan·Phase 2·NCT03443492·130 enrolled

Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Suspended·HHokkaido Gastrointestinal Cancer Study Group·Phase 1/2·NCT00209677·40 enrolled

Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

Not yet recruiting·CCSPC Ouyi Pharmaceutical Co., Ltd.·Phase 3·NCT06571461·408 enrolled

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00602745·61 enrolled

Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT00651742·28 enrolled

Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer

Unknown status·—·Phase 2·NCT02124317·60 enrolled

IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer

Unknown status·—·N/A·NCT02734680·70 enrolled

Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT00652054·39 enrolled

Maintenance Chemotherapy With S-1 vs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 4·NCT06779318·464 enrolled

Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Terminated·AAndrew Ko·Phase 2·NCT00429858·21 enrolled

Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers

Unknown status·TThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences·Phase 2·NCT01074996·92 enrolled

Esophageal Cancer12 trials

S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

Withdrawn·ZZhejiang Provincial People's Hospital·Phase 2·NCT02716688

Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)

Recruiting·SSun Yat-sen University·Phase 2·NCT06187597·140 enrolled

Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT

Not yet recruiting·—·Phase 2·NCT06598917·60 enrolled

Show 9 more trials

Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

Completed·FFudan University·Phase 2·NCT01831531·105 enrolled

Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

Unknown status·CChinese Academy of Medical Sciences·Phase 3·NCT02319187·240 enrolled

SOX-based CRT for Esophageal Cancer.

Withdrawn·ZZhejiang Provincial People's Hospital·Phase 1/2·NCT03991104

Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

Completed·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06048913·56 enrolled

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

Completed·—·Phase 2·NCT04207918·55 enrolled

S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

Completed·ZZhejiang Cancer Hospital·Phase 3·NCT02813967·298 enrolled

A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

Recruiting·BBeijing Konruns Pharmaceutical Co., Ltd.·Phase 3·NCT06194734·490 enrolled

Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer

Completed·CChinese Academy of Medical Sciences·Phase 2·NCT02725424·180 enrolled

S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

Completed·ZZhejiang Cancer Hospital·Phase 1·NCT01175447·12 enrolled

Adenocarcinoma5 trials

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03615326·738 enrolled

Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Unknown status·FFudan University·Phase 2·NCT05111444·65 enrolled

Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction

Completed·AAIO-Studien-gGmbH·Phase 1/2·NCT02564367·30 enrolled

Show 2 more trials

Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05687357·140 enrolled

Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma

Not yet recruiting·SSichuan University·Phase 2·NCT07374250·154 enrolled

Gastroesophageal Junction Adenocarcinoma4 trials

SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07384234·60 enrolled

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Terminated· Gilead logo

Gilead·Phase 1·NCT02862535·36 enrolled

Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·FFudan University·Phase 2·NCT06914687·30 enrolled

Show 1 more trial

A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02539225·191 enrolled

40 more indications

Gastric Adenocarcinoma3 trials

Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

Completed·CChinese Academy of Medical Sciences·Phase 2·NCT02370849·2 enrolled

S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients

Completed·SSun Yat-sen University·Phase 3·NCT01824459·576 enrolled

A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

Completed·CChinese Academy of Medical Sciences·Phase 2·NCT02301481·71 enrolled

Biliary Tract Cancer3 trials

Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Completed·KKansai Hepatobiliary Oncology Group·Phase 1·NCT01291615·6 enrolled

Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Completed·KKansai Hepatobiliary Oncology Group·Phase 2·NCT01815307·70 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06109779·760 enrolled

Nasopharyngeal Carcinoma3 trials

S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Completed·FFudan University·Phase 2·NCT03668366·133 enrolled

Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

Recruiting·MMing-Yuan Chen·Phase 2·NCT07070479·208 enrolled

A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT02878889·53 enrolled

Biliary Tract Carcinoma2 trials

A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection

Unknown status·FFudan University··NCT04856761·160 enrolled

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

Not yet recruiting·SShanghai East Hospital·N/A·NCT06171321·94 enrolled

Breast Cancer2 trials

Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Unknown status·SShandong University·Phase 4·NCT01849380·240 enrolled

Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer

Completed·JJapan Breast Cancer Research Network·Phase 2·NCT00438100·142 enrolled

Adjuvant Chemotherapy2 trials

A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

Completed·TTomoshi Tsuchiya·Phase 2·NCT01459185·55 enrolled

A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

Unknown status·PPeking University·Phase 2·NCT01679340·160 enrolled

Non-Small Cell Lung Cancer2 trials

Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT00652561·57 enrolled

Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT00651833·60 enrolled

Esophageal Adenocarcinoma2 trials

RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

Recruiting·—·Phase 1/2·NCT05403242·42 enrolled

Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

Completed· Sanofi logo

Sanofi·Phase 2·NCT00816543·41 enrolled

Advanced Solid Tumors2 trials

A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1·NCT00400023·12 enrolled

Sorafenib Plus S-1 in Advanced Solid Tumors

Completed·NNational Health Research Institutes, Taiwan·Phase 1·NCT01128998·30 enrolled

Oxaliplatin2 trials

A Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan

Completed·IInstitut du Cancer de Montpellier - Val d'Aurelle·Phase 1·NCT02387138·24 enrolled

A RCT of Oral S-1 in Combination With Sequential HAIC of Oxaliplatin After TACE in Patients With Advanced HCC

Unknown status·ZZhu Xu·Phase 4·NCT01997957·110 enrolled

Capecitabine1 trial

Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

Terminated·HHeikki Joensuu·Phase 2·NCT02216149·20 enrolled

Fruquintinib1 trial

Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC

Recruiting·MMeng Qiu·Phase 2·NCT06427005·66 enrolled

Recurrent or Metastatic NPC1 trial

Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC

Recruiting·SSun Yat-sen University·Phase 2·NCT06657690·56 enrolled

Trial1 trial

A Trial of TAS-114 in Combination With S-1

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1·NCT02454062·120 enrolled

Clinical Trial1 trial

Clinical Trial of Chemosensitivity Test

Completed·JJapan Clinical Cancer Research Organization·Phase 2·NCT00287755·300 enrolled

Urothelial Carcinoma1 trial

A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010

Active, not recruiting· Roche logo

Roche·Phase 1·NCT05867121·102 enrolled

HER2 Positive1 trial

Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

Not yet recruiting·TTao Zhang·Phase 2·NCT07243938·70 enrolled

Biliary Cancer1 trial

Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers

Completed·NNational Health Research Institutes, Taiwan·Phase 1·NCT03162510·18 enrolled

Gastroesophageal Junction Cancer1 trial

Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT01747707·40 enrolled

Metastatic Colorectal Cancer1 trial

Phase I Study of Biweekly SIRB Regimen for Metastatic Colorectal Cancer

Withdrawn·FFujian Cancer Hospital·Phase 1·NCT03380689

Rectal Cancer1 trial

RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

Unknown status·CClinical Research Support Center Kyush·Phase 2·NCT02280070·110 enrolled

Concurrent Chemoradiotherapy1 trial

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06341595·40 enrolled

Ascites1 trial

The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites

Unknown status·FFudan University·Phase 2·NCT02779608·50 enrolled

High Risk Patients1 trial

S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

Terminated·KKangbuk Samsung Hospital·Phase 2·NCT02191566·8 enrolled

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02359058·18 enrolled

AIN1 trial

S-1-induced Lacrimal Drainage Obstruction

Unknown status·SSeoul National University Bundang Hospital··NCT01486472·200 enrolled

Advanced Cancer1 trial

First Line Chemotherapy for Advanced Cancer

Terminated·CChinese Academy of Medical Sciences·Phase 2·NCT01980810·36 enrolled

Adjuvant Therapy1 trial

Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

Withdrawn·ZZhejiang University·Phase 2·NCT02129322

Locally Advanced Head and Neck Cancer1 trial

Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer

Completed·—·Phase 2·NCT01645748·35 enrolled

Esophageal Squamous Cell Cancer1 trial

Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

Completed·SSun Yat-sen University·Phase 2·NCT02606916·42 enrolled

Phase II1 trial

ONO-4538 Phase II Rollover Study (ONO-4538-98)

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT04566380·59 enrolled

Cancer1 trial

Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

Unknown status·HHamamatsu University·Phase 2·NCT00197431

Colorectal Adenocarcinoma1 trial

Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma

Withdrawn·FFujian Cancer Hospital·Phase 3·NCT03708536

Randomized1 trial

A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT02855125·128 enrolled

Intravenous1 trial

A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

Completed· Sanofi logo

Sanofi·Phase 1·NCT00479076·22 enrolled

Rectal Carcinoma1 trial

Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

Unknown status·JJapan Clinical Cancer Research Organization·Phase 1/2·NCT01227239·45 enrolled

Cholangiocarcinoma1 trial

Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

Completed·FFirst People's Hospital of Hangzhou·N/A·NCT02592538·66 enrolled

Locally Advanced Gastric Cancer1 trial

A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX/XELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Not yet recruiting·SShanghai Changzheng Hospital·Phase 2·NCT07621484·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 139 trial records for S-1. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — S-1 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for S-1. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Taiho Oncology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Taiho Oncology, Inc.

S-1

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Gastric Cancer46 trials

Pancreatic Cancer19 trials

Esophageal Cancer12 trials

Adenocarcinoma5 trials

Gastroesophageal Junction Adenocarcinoma4 trials

Gastric Adenocarcinoma3 trials

Biliary Tract Cancer3 trials

Nasopharyngeal Carcinoma3 trials

Biliary Tract Carcinoma2 trials

Breast Cancer2 trials

Adjuvant Chemotherapy2 trials

Non-Small Cell Lung Cancer2 trials

Esophageal Adenocarcinoma2 trials

Advanced Solid Tumors2 trials

Oxaliplatin2 trials

Capecitabine1 trial

Fruquintinib1 trial

Recurrent or Metastatic NPC1 trial

Trial1 trial

Clinical Trial1 trial

Urothelial Carcinoma1 trial

HER2 Positive1 trial

Biliary Cancer1 trial

Gastroesophageal Junction Cancer1 trial

Metastatic Colorectal Cancer1 trial

Rectal Cancer1 trial

Concurrent Chemoradiotherapy1 trial

Ascites1 trial

High Risk Patients1 trial

Unresectable1 trial

Colorectal Cancer1 trial

Combination Therapy1 trial

AIN1 trial

Advanced Cancer1 trial

Adjuvant Therapy1 trial

Locally Advanced Head and Neck Cancer1 trial

Esophageal Squamous Cell Cancer1 trial

Phase II1 trial

Cancer1 trial

Colorectal Adenocarcinoma1 trial

Randomized1 trial

Intravenous1 trial

Rectal Carcinoma1 trial

Cholangiocarcinoma1 trial

Locally Advanced Gastric Cancer1 trial

References

Drug Info

Quick Facts

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