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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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).
4 cycles, Oxaliplatin 130 mg/m², Capecitabine 825 mg/m²
Administer Capecitabine at a dose of 825 mg/m², twice daily, orally on radiotherapy days
IV, 5 mg/kg every 3 weeks
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGTumor Complete Response (CR) Rate
CR including pCR and cCR
Time frame: 2 years
MPR rate
Time frame: 4 years
R0 Resection Rate
Time frame: 4 years
Adjacent Organ Preservation Rate
Time frame: 4 years
EFS rate
Time frame: 3 years
OS rate
Time frame: 3 years
Adverse events
Time frame: 4 years
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