420
Participants
Start Date
April 30, 2024
Primary Completion Date
April 30, 2027
Study Completion Date
April 30, 2027
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.
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.
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.
Lead Sponsor
Biotech Pharmaceutical Co., Ltd.
OTHER