Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Refractory Metastatic Colorectal Cancer
Interventions
DRUG

Nimotuzumab injection

Nimotuzumab will be administered weekly (dose of nimotuzumab depends on part A) until disease progression, unacceptable toxicity, withdrawal of consent or death due to any cause.

DRUG

Placebo

Placebo will be administered weekly (dose of placebo depends on part A) until disease progression, unacceptable toxicity, withdrawal of consent or death due to any cause.

DRUG

Trifluridine/tipiracil

Trifluridine/tipiracil will be administered (35 mg/m2) twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest.

All Listed Sponsors
lead

Biotech Pharmaceutical Co., Ltd.

OTHER