Actively Recruiting
Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color）
Led by Hebei Medical University Fourth Hospital · Updated on 2025-07-01
128
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 or 1
- Confirmed diagnosis of colon adenocarcinoma (including mucinous type) with pMMR/MSS status
- Primary tumor located in left or right colon as defined
- Clinical staging confirmed as cT4N any M0 by imaging according to AJCC 8th edition
- Blood counts and liver, kidney, and coagulation function within specified safe ranges
- Agreement to use effective contraception during the study and for 6 months after last treatment if of childbearing potential
- Willingness to provide informed consent and complete all treatments and follow-up
You will not qualify if you...
- Neuroendocrine carcinoma, squamous cell carcinoma, or non-adenocarcinoma components over 50%
- Presence of distant metastasis including peritoneal, non-regional lymph node, or organ metastases
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for colon cancer
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Active infections such as HIV or hepatitis B/C requiring antiviral treatment
- Severe cardiovascular diseases including recent myocardial infarction, unstable angina, uncontrolled hypertension
- History of other cancers except certain cured cancers with disease-free period over 5 years
- Uncontrolled diabetes or thyroid disorders needing medication
- Severe chronic bowel diseases like active Crohn's disease or ulcerative colitis
- History of radiation enteritis or extensive abdominal adhesions affecting radiotherapy
- Unrecovered bone marrow suppression below defined blood count thresholds
- Liver function with Child-Pugh class B or worse, or poor kidney function with eGFR below 60
- Pregnant or breastfeeding women
- Cognitive impairment or psychiatric disorders affecting compliance
- Participation in other interventional clinical trials
- Investigator judgment deeming patient unsuitable for study participation
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Trial Site Locations
Total: 1 location
1
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
Research Team
F
Fengpeng Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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