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NOT YET RECRUITING
NCT07007728
PHASE2

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

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Iparomlimab/Tuvonralimab Combined With Bevacizumab and CAPEOX as Conversion Therapy in Patients With Right-Sided or RAS-mutant, Microsatellite Stable, Initially Unresectable Colorectal Cancer Liver Metastasis: A Prospective, Open-Label, Single-Arm, Single-Center, Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-06-01

Completion Date

2026-12-31

Last Updated

2025-06-06

Healthy Volunteers

No

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.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China