RecruitingPhase 1Phase 2NCT06379399

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

Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type Metastatic Colorectal Cancer: A Single-center, Prospective Phase Ib/II Study

Sponsor

Wangxia LV

Enrollment

26 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

Summary

This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two chemotherapy drugs — trifluridine/tipiracil plus cetuximab — as a third-line or later treatment for patients with metastatic colorectal cancer (cancer that has spread) whose tumors have normal (wild-type) RAS and BRAF genes. **You may be eligible if...** - You have metastatic colon cancer confirmed by tissue testing - Your tumor has wild-type (normal) RAS and BRAF genes - You have already received at least two prior treatment regimens - You are in good physical condition (ECOG 0-1) - Your cancer can be measured on scans **You may NOT be eligible if...** - Your tumor has RAS or BRAF mutations - You have not yet received two prior lines of treatment - Your overall health is too poor for chemotherapy - You previously received anti-EGFR therapy but did not achieve at least a partial response Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCetuximab

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

DRUGTrifluridine/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;