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NOT YET RECRUITING
NCT07797244
PHASE2

A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)

Sponsor: Dai, Guanghai

View on ClinicalTrials.gov

Summary

This single-arm phase II trial enrolls patients with RAS-mutant, microsatellite-stable (MSS) unresectable colorectal cancer liver metastases receiving first-line treatment with Retlirafusp alfa combined with XELOX (capecitabine plus oxaliplatin) and bevacizumab. The primary endpoint is objective response rate (ORR). A total of 46 patients will be enrolled, and the study is expected to be completed between 2026 and 2029.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-10-29

Completion Date

2029-10

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

Retlirafusp alfa+XELOX+Bevacizumab Treatment

Enrolled subjects received Retlirafusp alfa injection (1800 mg, IV, Day 1, every 3 weeks) + bevacizumab (7.5 mg/kg, IV, Day 1, every 3 weeks) plus XELOX (capecitabine 1,000 mg/m², oral, twice daily, Days 1-14; and oxaliplatin 130 mg/m², IV, Day 1, every 3 weeks). Oxaliplatin was discontinued after a maximum of 8 cycles, while the other agents were continued, marking the transition to the maintenance phase. Immunotherapy was administered for no more than 2 years.

Locations (1)

Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, China