Health TrialsbyHealthPanel

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)

ConditionAdvanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDai, Guanghai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-75 years;

Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;

MSS/pMMR;

RAS-mutant;

Disqualifiers

History of or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;

History of severe cardiovascular disease, such as congestive heart failure (New York Heart Association Class III-IV), myocardial infarction within the past 6 months, unstable angina, or severe arrhythmias;

Presence of active infections (e.g., sepsis, active tuberculosis) or uncontrolled autoimmune diseases;

History of severe gastrointestinal diseases, such as active peptic ulcers, intestinal obstruction, or gastrointestinal bleeding, which may affect drug absorption or increase treatment-related risks;

Trial design

Design model

Single group

Treatments tested in this trial

  • Retlirafusp alfa+XELOX+Bevacizumab Treatment

    Drug

    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.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: The Retlirafusp alfa in combination with XELOX and bevacizumab treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The proportion of patients with a confirmed complete response or partial response

Time frame
24 months

Secondary outcomes

1

Progress-free Survival(PFS)

The time from enrollment until tumor progression or death from any cause, whichever occurred first

Time frame
24 months
2

Overall Survival (OS)

The time from randomization to death from any reason

Time frame
24 months
3

Incidence of Adverse Events

Incidence of Adverse Events According to the CTCAE 6.0

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dai, Guanghai

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: