FOLFOXIRI

Phase 3Small molecule

SSun Yat-sen University

FOLFOXIRI is one of 93 small molecule programs targeting Locally-advanced Rectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Locally-Advanced Rectal CancerNot yet recruiting

Stage III Colon CancerRecruiting

Rectal CancerRecruiting

Clinical TrialRecruiting

Locally-Advanced Rectal CancerPhase 3

Not yet recruiting

Stage III Colon CancerPhase 2

Recruiting

Rectal CancerPhase 3

Recruiting

Clinical TrialPhase 3

Recruiting

Competition

Competitive Landscape

136 competitors in Clinical Trial

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

3 2

Venclexta

AbbVie

Phase 3

2 3

Avelox

Bayer

Phase 3

2 4

Paraplatin

AAvyxa

Phase 3

2 5

Opzelura

DDizal Pharmaceuticals

Phase 3

1 6

Potassium Iodide

MMeda Pharmaceuticals

Phase 3

1 7

Ablysinol

CSL Behring

Phase 3

1 8

Nascobal

GGrupo Espanol de Tumores Neuroendocrinos

Phase 3

1 9

Cytoxan

BBaxter Healthcare Corporation

Phase 2

3 10

Grafapex

MMedexus Pharma, Inc.

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Stage III Colon Cancer

NCT06242418

Q1 2027

Phase 2Active, not recruiting

Colorectal Neoplasms Malignant

NCT07821333

Q3 2027

Phase 3Recruiting

Rectal Cancer

NCT05201430

Q3 2028

Phase 3Recruiting

Clinical Trial

NCT03671252

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer5 trials

FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)

Completed·AAIO-Studien-gGmbH·Phase 2·NCT01328171·93 enrolled

FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer

Completed·GGruppo Oncologico del Nord-Ovest·Phase 3·NCT01219920·244 enrolled

FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer

Unknown status·SSun Yat-sen University·Phase 2·NCT02128425·162 enrolled

Show 2 more trials

FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer

Completed·SSun Yat-sen University·Phase 2·NCT02063529·101 enrolled

FOLFOXIRI With or Without Bevacizumab as First-line Treatment for Unresectable Liver-only Metastatic Colorectal Cancer Patients With RAS Mutation-type

Unknown status·SSun Yat-sen University·Phase 2·NCT02350530·138 enrolled

Locally-advanced Rectal Cancer3 trials

Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Unknown status·RRenJi Hospital·Phase 2·NCT02942563·100 enrolled

Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer

Not yet recruiting·JJ. W. A. Burger·Phase 3·NCT07472868·394 enrolled

Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

Completed·SSun Yat-sen University·Phase 2·NCT02217020·100 enrolled

Patients With Locally Advanced Rectal Cancer2 trials

Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer

Unknown status·—·Phase 2·NCT03484221·30 enrolled

Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Completed·AAiping Zhou·Phase 2·NCT03443661·50 enrolled

Pancreatic Cancer2 trials

FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

Completed·AAzienda Ospedaliero, Universitaria Pisana·Phase 2·NCT02351219·50 enrolled

Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

Unknown status·AAzienda Ospedaliero, Universitaria Pisana·Phase 3·NCT02355119·310 enrolled

Metastatic Colon Cancer1 trial

Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI

Completed·HHanoi Medical University··NCT03504618·39 enrolled

10 more indications

Neoadjuvant Treatment1 trial

FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer

Withdrawn·GGuangxi Medical University·Phase 2·NCT03161574

Chemotherapy1 trial

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

Terminated·—·Phase 2·NCT03117972·54 enrolled

Locally Advanced Colon Cancer1 trial

Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Unknown status·—·Phase 2·NCT03484195·30 enrolled

Stage III Colon Cancer1 trial

CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)

Recruiting·WWest China Hospital·Phase 2·NCT06242418·60 enrolled

Rectal Cancer1 trial

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Recruiting·FFudan University·Phase 3·NCT05201430·300 enrolled

Clinical Trial1 trial

Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation

Recruiting·SSun Yat-sen University·Phase 3·NCT03671252·776 enrolled

Colon Cancer Liver Metastases1 trial

FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

Unknown status·FFudan University·Phase 2·NCT04832776·160 enrolled

Colorectal Cancer1 trial

Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer

Unknown status·—·Phase 2·NCT03487939·30 enrolled

Organ Preservation1 trial

Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer

Completed·SStanford University·Phase 2·NCT04380337·38 enrolled

Colorectal Neoplasms Malignant1 trial

Phase II Randomized Trial to Assess the Effect of Intensive vs Standard Adjuvant Chemotherapy in Localized Colon Cancer With Circulating Tumor DNA

Active, not recruiting·FFundación para la Investigación del Hospital Clínico de Valencia·Phase 2·NCT07821333·45 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for FOLFOXIRI. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — FOLFOXIRI compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for FOLFOXIRI. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sun Yat-sen University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSun Yat-sen University

FOLFOXIRI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q3 2028

Trials by Indication[1]

Metastatic Colorectal Cancer5 trials

Locally-advanced Rectal Cancer3 trials

Patients With Locally Advanced Rectal Cancer2 trials

Pancreatic Cancer2 trials

Metastatic Colon Cancer1 trial

Neoadjuvant Treatment1 trial

Chemotherapy1 trial

Locally Advanced Colon Cancer1 trial

Stage III Colon Cancer1 trial

Rectal Cancer1 trial

Clinical Trial1 trial

Colon Cancer Liver Metastases1 trial

Colorectal Cancer1 trial

Organ Preservation1 trial

Colorectal Neoplasms Malignant1 trial

References

Drug Info

Quick Facts

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