RecruitingPhase 2NCT06949111

Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer(Neo-Color)

Efficacy and Safety of Conversion Therapy for pMMR/MSS T4M0 Colon Cancer Patients Treated With Radiotherapy and Systemic Therapy: a Prospective, Open-label, Multi-center, Randomized Controlled Trial(Neo-Color)


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

128 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of conversion therapy using radiotherapy combined with systemic treatment (chemotherapy + immune checkpoint inhibitors) for patients with pMMR/MSS T4M0 stage colon cancer. The main questions it aims to answer are: 1. Can the combination of radiotherapy and systemic treatment improve the R0 resection rate and complete response (CR) rate compared to chemotherapy alone? 2. Does this combination therapy enhance the tumor immune microenvironment, leading to better long-term outcomes? Researchers will compare the experimental group receiving concurrent chemoradiotherapy (CCRT) followed by 4 cycles of CAPOX + Iparomlimab and Tuvonralimab Injection with the control group receiving 4 cycles of CAPOX alone to see if the combination therapy offers superior efficacy. Participants will: 1. Undergo preoperative CCRT combined with one cycle of Iparomlimab and Tuvonralimab Injection, followed by 4 cycles of CAPOX + Iparomlimab and Tuvonralimab Injection in the experimental group. 2. Receive 4 cycles of CAPOX in the control group. 3. After the initial treatment regimen, surgical candidates will undergo surgery followed by an additional 4 cycles of CAPOX. Non-surgical candidates will continue with 4 more cycles of CAPOX, completing a total of 8 cycles. Efficacy will be re-evaluated after the completion of 8 cycles.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether radiation therapy combined with systemic drug treatment (chemotherapy and/or targeted therapy) can shrink large, locally advanced colon tumors (T4, no distant spread) enough that surgery becomes safe and effective. It aims to convert what was previously inoperable cancer into operable cancer. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with colon adenocarcinoma (a common type of colon cancer) confirmed by tissue biopsy - Your cancer is classified as pMMR/MSS (a specific genetic marker) - Your tumor has grown through the colon wall and possibly into nearby tissue (T4 stage), but has not spread to distant organs (M0) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have already received prior treatment for this cancer - You have significant heart, liver, or kidney problems - You have active autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONradiotherapy

Radiotherapy: Administer three-dimensional conformal/intensity-modulated/TOMO radiotherapy with a conventional fractionation schedule of 36-41.4 Gy in 20-23 fractions (1.8 Gy per fraction).

DRUGCAPOX

4 cycles, Oxaliplatin 130 mg/m², Capecitabine 825 mg/m²

DRUGCapecitabine

Administer Capecitabine at a dose of 825 mg/m², twice daily, orally on radiotherapy days

DRUGIparomlimab and Tuvonralimab Injection

IV, 5 mg/kg every 3 weeks


Locations(1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT06949111


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