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

NCT06949111 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

radiotherapy

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).

DRUG

CAPOX

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

DRUG

Capecitabine

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

DRUG

Iparomlimab and Tuvonralimab Injection

IV, 5 mg/kg every 3 weeks

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-02-28
Completion
2029-03-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06949111 on ClinicalTrials.gov