OncoMatch/Clinical Trials/NCT06949111
Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color）
Is NCT06949111 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAPOX and Capecitabine for colon cancer.
Treatment: CAPOX · Capecitabine · Iparomlimab and Tuvonralimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 proficient MMR
identified as pMMR/MSS type
Required: MSH2 proficient MMR
identified as pMMR/MSS type
Required: MSH6 proficient MMR
identified as pMMR/MSS type
Required: PMS2 proficient MMR
identified as pMMR/MSS type
Disease stage
Required: Stage CT4NANYM0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Cannot have received: chemotherapy
Cannot have received: targeted therapy
Cannot have received: immunotherapy
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 × 10^9/l, platelets ≥ 100 × 10^9/l, hemoglobin ≥ 90 g/l
Kidney function
creatinine ≤ 1.5 × uln or creatinine clearance rate ≥ 60 ml/min (cockcroft-gault formula)
Liver function
alt/ast ≤ 2.5 × uln, total bilirubin ≤ 1.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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