MedTrace Logo

A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer

NCT07446387 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-12

No results posted yet for this study

Summary

This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.

Conditions

  • Metastatic Colorectal Cancer (CRC)

Interventions

DRUG

Iparomlimab and tuvonralimab

Induction Phase: Iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + bevacizumab (7.5 mg/kg, Q3W, D1) + CAPOX regimen (oxaliplatin 130 mg/m², Q3W, D1; capecitabine 1,000 mg/m², BID, D1-14, Q3W) / mCAPIRI (irinotecan 180 mg/m², Q3W, D1; capecitabine 800 mg/m², BID, D1-14, Q3W) alternating every 42 days, assessed every 6 weeks, for a maximum of 6 cycles. Maintenance Phase: Iparomlimab and tuvonralimab 5 mg/kg, Q3W, D1 + bevacizumab 7.5 mg/kg, Q3W, D1 + capecitabine 800-1,000 mg/m², BID, D1, Q3W. Patients with CR/PR/NED or SD are allowed to receive maintenance therapy until disease progression or intolerable toxicity.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Principal Investigators

  • Liangjun Zhu, Dr · Jiangu Cancer Hospital

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
2026-05-30
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07446387 on ClinicalTrials.gov