Irinotecan, TAS-102 Plus Bevacizumab as a Third-Line or Beyond Therapy in mCRC Patients

Metastatic Colorectal Cancer Clinical Trial

Official title: Phase II Study of Irinotecan Plus Trifluridine/Tipiracil (TAS-102) in Combination With Bevacizumab as a Third-Line or Beyond Therapy for Patients With Metastatic Colorectal Cancer (mCRC)

Status Active, not recruiting

Clinical Trial Summary

Currently, the approved third-line treatments for metastatic colorectal cancer (mCRC) include regorafenib, fruquintinib, and trifluridine/tipiracil(TAS-102). In recent years, several phase I/II studies evaluated the combination of TAS-102 and bevacizumab in mCRC patients who were refractory to standard therapies and showed promising antitumor efficacy and manageable toxicity. In this single-center phase II study, the investigators explored the efficacy and safety of irinotecan, TAS-102, plus bevacizumab in a third-line or beyond therapy for patients with mCRC.

Clinical Trial Description

The mCRC patients who are refractory to standard therapies and need a third-line or beyond therapy are eligible. Patients who previously received irinotecan while progressing during maintenance therapy are also eligible.

These patients received an intravenous infusion of irinotecan (150mg/m2 on day 1) plus bevacizumab (5 mg/kg on day 1) and an oral administration of TAS-102(30 mg/m2 given bid on days 1-5), repeated every 14 days.

The primary endpoint was the objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT06403709
• Study type: Interventional
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Completion date: August 1, 2026