Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

December 31, 2025

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

Cetuximab

Cetuximab will be administered at a fixed dose of 500 mg/m2 once every 2 weeks;

DRUG

Trifluridine/Tipiracil

"Phase I:~1. 6 patients (male and female) will be enrolled to evaluate safety. Patients will receive Trifluridine/Tipiracil at a dose of 35mg/m2 (maximum single dose of 80 mg). Patients will be followed up for Dose-Limiting Toxicities (DLTs) (2 Cycles, Day 1-Day 28). If ≤2 patients experience DLTs (2 Cycles, Day 1-Day 28), the study will proceed to Phase II with a dose of 35mg/m2. If ≥3 patients experience DLTs (2 Cycles, Day 1-Day 28), the study will proceed to Phase II with a dose of 30mg/m2.~2. Based on the results of the 35mg/m2 dose group, 6 patients (male and female) will be enrolled in the 30mg/m2 dose group to evaluate safety. Patients will be followed up for DLTs (2 Cycles, Day 1-Day 28). If ≤2 patients experience DLTs (1 Cycle, Day 1-Day 28), the study will proceed with a dose of 30mg/m2 in Phase II.~Phase II:~Trifluridine/Tipiracil: po, twice daily from Day 1-5, every two weeks, based on the recommended dose from Phase I;"

Trial Locations (1)

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Wangxia LV

OTHER