Actively Recruiting
Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-26
38
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Most colorectal cancers belong to the microsatellite stable (MSS) or proficient mismatch repair (pMMR) subtypes, with limited response to PD-1 inhibitors. Radiotherapy can increase the release of tumor-associated antigens, thereby improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer. Tumor-draining lymph nodes are important sites for PD-1 inhibitors to exert antitumor effects, and studies have reported that direct radiation-induced damage and fibrosis can inhibit lymph node drainage and anti-tumor function. Accumulating evidence indicates that low-dose radiotherapy reprograms the tumor microenvironment (TME), transforming immunosuppressive 'cold' tumors into immunostimulatory 'hot' tumors. This transition is mediated by modulating the gut microbiota, eliciting innate and adaptive immune responses, inhibiting immunosuppressive cells, and promoting the infiltration of T and B lymphocytes.Therefore, this study aims to evaluate whether node-sparing low-dose radiotherapy (1Gy/8f) concurrent with chemotherapy and PD-1 inhibitor can improve the pathological complete response (pCR) rate, enhance tolerability, and improve prognosis in patients with pMMR/MSS high-risk locally advanced colon cancer.
CONDITIONS
Official Title
Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent.
- Age 18 to 75 years at enrollment.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 2 years.
- Histologically confirmed adenocarcinoma of the colon without squamous or sarcomatoid components.
- Tumor shows proficient mismatch repair (positive expression of MSH1, MSH2, MSH6, and PMS2) or microsatellite stable status.
- Tumor staged as T4 and/or N+ (Stage IIB-III) per AJCC 8th edition by imaging.
- Evaluated by a surgeon and eligible for R0 curative resection.
- No previous systemic or local anti-tumor therapy for colon cancer.
- Agree to provide tumor tissue and blood samples during screening and study.
- Adequate organ function including specified hematology, renal, hepatic, coagulation, and cardiac parameters.
- Female participants of childbearing potential must have a negative pregnancy test and agree to effective contraception from screening through 120 days after last study drug dose.
- Willing and able to comply with study visits, treatments, and tests.
You will not qualify if you...
- Presence of suspicious metastatic lesions or unresectable locally advanced disease.
- History of other malignancies within 5 years except certain cured local cancers.
- Use of investigational drugs or devices within 4 weeks before study drug.
- Intestinal obstruction, bowel perforation, or bleeding needing emergency surgery.
- Multiple primary colorectal cancers.
- Prior pelvic or abdominal radiotherapy.
- Inability to swallow pills or malabsorption conditions.
- Prior systemic or local anti-tumor therapy for locally advanced colon cancer.
- Use of non-specific immunomodulatory therapy within 2 weeks or certain herbal anti-tumor medicines within 1 week before study.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History of pneumonitis requiring steroids or current interstitial lung disease.
- Severe bleeding or coagulation disorders or long-term anticoagulation therapy.
- Uncontrolled significant comorbidities affecting compliance or consent.
- History of myocarditis, cardiomyopathy, malignant arrhythmia, or serious cardiac events within specified recent periods.
- Active or history of inflammatory bowel disease.
- Severe infection within 4 weeks or active infection requiring treatment within 10 days pre-study.
- Major surgery or severe trauma within 30 days prior; minor surgery within 3 days.
- History of immunodeficiency, positive HIV test, or long-term immunosuppressants use.
- Known active tuberculosis or syphilis.
- History of allogeneic organ or stem cell transplantation.
- Untreated active Hepatitis B or C infection.
- Receipt or planned receipt of live vaccines within 30 days of treatment.
- Known allergy to study drugs or severe reactions to monoclonal antibodies.
- History of psychiatric illness, drug, alcohol, or substance abuse.
- Pregnant or breastfeeding women.
- Any condition that may interfere with study participation or safety.
- Diseases or symptoms causing high medical risk or survival uncertainty, such as cachexia or low BMI.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanxin Luo, M.D., Ph.D.
CONTACT
Y
Yikan Cheng, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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