drugset / Trial / NCT07549906

Neoadjuvant Iparomlimab/Tuvonralimab Plus CAPEOX Versus Iparomlimab/Tuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study

NCT07549906

Phase 2 Not yet recruiting 45 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this prospective, single-center, multi-cohort clinical trial is to evaluate the efficacy and safety of neoadjuvant Iparomlimab/Tuvonralimab combined with CAPEOX, with or without propranolol, in patients with locally advanced pMMR (MSS) colon cancer. The main questions it aims to answer are: * What is the major pathological response (MPR) rate after neoadjuvant treatment and curative surgery (e.g., ≤10% viable tumor cells in the resected primary tumor)? * What are the key secondary outcomes (e.g., R0 resection rate, tumor regression grade, objective response rate, disease-free survival) and the safety/tolerability profile of these neoadjuvant regimens? If there is a comparison group: Researchers will compare Cohort A (Iparomlimab/Tuvonralimab + CAPEOX) versus Cohort B (Iparomlimab/Tuvonralimab + CAPEOX + propranolol) to see whether adding propranolol improves pathological and clinical responses while maintaining acceptable safety. Participants will: * Receive neoadjuvant Iparomlimab/Tuvonralimab + CAPEOX for a protocol-defined number of cycles, with or without propranolol depending on cohort assignment. * Undergo curative-intent surgical resection after completing neoadjuvant therapy. * Be followed for postoperative treatment, adverse events, and longer-term outcomes (e.g., recurrence and survival), and may contribute tumor/blood samples for exploratory biomarker analyses related to treatment response.

Timeline

Start
2026-04-20
Primary completion
2026-07-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody 5 mg/kg Intravenous
Subject Propranolol Small molecule 10 mg Oral
Subject Tuvonralimab Monoclonal antibody 5 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous