Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

March 11, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

May 1, 2026

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Irinotecan Liposome

"In dose escalation study, irinotecan liposome injection will be administered by an intravenous infusion at three doses of 60 mg/m2, 70 mg/m2 and 80 mg/m2, d1, 14 days per cycle. In expansion study, irinotecan liposome injection will be administered by an intravenous infusion at the dose of RP2D, d1, 14 days per cycle.~Until the disease progresses or surgery is possible."

DRUG

Oxaliplatin

85 mg/m2, intravenously infusion, d1, 14 days per cycle, up to 12 cycles.

DRUG

5-FU

2400mg/m2, intravenous infusion, d1-2, 14 days per cycle. Until the disease progresses or surgery is possible.

DRUG

LV

400mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.

DRUG

Bevacizumab

5mg/kg, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.It is used to patients in dose escalation phase and with gene mutation in extension phase.

DRUG

Cetuximab

500mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.For wild-type patients in extended phase studies.

Trial Locations (1)

200032

RECRUITING

Zhongshan Hospital Affiliated to Fudan University, Shanghai

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Shanghai Zhongshan Hospital

OTHER

NCT06225622 - Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter