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CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer

NCT07383285 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-02-03

No results posted yet for this study

Summary

Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation/pMMR metastatic rectal cancer patients.

Study endpoint:

Primary endpoint: 12-month progression-free survival rate (PFSR)

Secondary endpoints:

* The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);
* The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).

This study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:

The treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).

The control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).

Conditions

  • Rectal Neoplasms Malignant

Interventions

DRUG

Iparomlimab and Tuvonralimab

(Experimental group) PD-1/CTLA-4 Antibody

RADIATION

Radiotherapy to the primary site

(Experimental group) Radiotherapy to the primary site of rectal

DRUG

Capecitabine

(both groups)

DRUG

Bevacizumab

(both groups)

DRUG

Oxaliplatin injection

(both groups)

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2029-12-31
Completion
2029-12-31

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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 NCT07383285 on ClinicalTrials.gov