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Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC

Colorectal Neoplasms Malignant Clinical Trial

Official title:
Safety of Cetuximab in Combination With Trifluridin Tipiracil in the Third-line Treatment of RASwt Metastatic Colorectal Cancer

Clinical Trial Summary

This was a single-arm, prospective study to investigate the safety of cetuximab in combination with trifluridin tipiracil (TAS-102) in the third-line treatment of Chinese patients with RAS wild-type mCRC.

Clinical Trial Description

This was a single-arm, prospective study to investigate the safety of cetuximab in combination with trifluridin tipiracil (TAS-102) in the third-line treatment of Chinese patients with RAS wild-type mCRC. Cetuximab will be administered at a fixed dose of 500 mg/m2 once every 2 weeks; trifluridin tipiracil will be administered in a dose de-escalation design: dose level 1: 35 mg/m2 twice daily on days 1-5 once every 2 weeks; after 1 cycle will be observed, and if ≤ 2 patients experience DLT, this dose level will be the recommended phase II dose; if ≥ 3 patients experience DLT, additional 6 patients will receive dose level 0. ( Dose level 0: 30 mg/m2, twice daily, Days 1-5, once every 2 weeks;) If ≤ 2 individuals experience DLT, this dose level is the recommended Phase II dose; if ≥ 3 individuals experience DLT, the study will be stopped. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05155124
Study type Interventional
Source Wuhan Union Hospital, China
Contact Hongli Liu, PhD
Phone +86-027-85871962
Email hongli_liu@hust.edu.cn
Status Recruiting
Phase Phase 1
Start date September 2022
Completion date April 2023
View Details
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