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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)

NCT07797244 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)

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.

Sponsors & Collaborators

  • Dai, Guanghai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-29
Primary Completion
2029-04-30
Completion
2029-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797244 on ClinicalTrials.gov