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Iparomlimab/Tuvonralimab Combined With Bevacizumab and CAPEOX as Conversion Therapy for Colorectal Cancer Liver Metastasis

NCT07007728 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-06-06

No results posted yet for this study

Summary

More than half of colorectal cancer (CRC) patients present with RAS mutations or right-sided primary tumors; however, objective response rates (ORRs) to bevacizumab combined with chemotherapy remain suboptimal. Additionally, approximately 95% of metastatic CRC (mCRC) cases are microsatellite stable (MSS), where immune checkpoint inhibitor monotherapy demonstrates limited efficacy, necessitating combination strategies. Iparomlimab/tuvonralimab is the first bifunctional combination of anti-PD-1/anti-CTLA-4 monoclonal antibodies, which has shown therapeutic promise in first-line mCRC when combined with bevacizumab and capecitabine plus oxaliplatin (CAPEOX). Nevertheless, whether improved treatment response rates in mCRC patients can lead to higher surgical conversion rates remains unclear. This study evaluates the efficacy and safety of iparomlimab/tuvonralimab combined with bevacizumab and CAPEOX as conversion therapy in patients with right-sided or RAS-mutant, MSS, initially unresectable colorectal cancer liver metastasis.

Conditions

  • Colorectal Neoplasms
  • Secondary Malignant Neoplasm of Liver

Interventions

DRUG

Iparomlimab/Tuvonralimab

5mg/kg intravenous infusion on Day 1 of each cycle (every 21 days). Duration: 3 or 6 cycles

DRUG

Bevacizumab + CAPEOX

Bevacizumab: 7.5mg/kg intravenous infusion on Day 1 of each cycle (every 21 days). Capecitabine: 1000 mg/m2 twice daily orally on Day 1-14 of each cycle (every 21 days). Oxaliplatin: 130 mg/m2 intravenous infusion on Day 1 of each cycle (every 21 days). Duration: Conversion therapy phase: 3 or 6 cycles; Postoperative follow-up phase (for patients with successful conversion surgery ): 3 or 6 cycles (a total perioperative duration of 9 cycles); Maintenance phase (for patients without successful conversion surgery ): Continuous therapy until disease progression, intolerable adverse events, withdrawal of consent, loss to follow-up, death, or study termination.

PROCEDURE

Surgical resection ± ablation or stereotactic radiotherapy (if applicable)

After 3 or 6 cycles of conversion therapy, surgical resection ± ablation or stereotactic radiotherapy will be provided if applicable.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT07007728 on ClinicalTrials.gov