Actively Recruiting
Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer
Led by Sir Run Run Shaw Hospital · Updated on 2026-01-06
52
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor ("lymph-node-sparing" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1/CTLA-4 immune checkpoint inhibitors. Two weeks after completing chemo-immunotherapy, tumor response is assessed. Patients who achieve a clinical complete response may enter a "watch-and-wait" program; others will undergo local excision or total mesorectal excision (TME) as appropriate. The primary endpoint is the rate of complete response (clinical and pathological). Secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life measures. Results from a pilot study suggest that this regimen may substantially improve complete response rates while reducing radiation-related toxicity, potentially allowing more patients to avoid radical surgery and permanent stoma.
CONDITIONS
Official Title
Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who want to preserve the anus and agree to neoadjuvant therapy
- Male or female aged 18 to 80 years
- Diagnosed with low rectal cancer within 7 cm from the tumor's lower edge to the anal verge, clinical stage cT2-3N0M0
- Histologically confirmed rectal adenocarcinoma with MSI-L or MSS status or pMMR by immunohistochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No previous anti-tumor treatment, immunotherapy, or pelvic radiation
- Signed informed consent form
You will not qualify if you...
- History of other malignant tumors besides rectal cancer
- Presence of distant metastases before enrollment
- Metastatic regional or non-regional lymph nodes detected by MRI or CT
- Obstruction, perforation, or bleeding requiring emergency surgery
- Severe other diseases with expected survival less than or equal to 5 years
- Allergy to any therapy components
- Immunosuppressive or systemic hormone therapy within 1 month before treatment
- Contraindications to radiotherapy or chemotherapy
- Participation in another experimental drug trial within 30 days prior to screening
- Conditions leading to study termination such as alcoholism, drug abuse, serious illnesses, immune deficiency (e.g., HIV)
- Vulnerable groups including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or breastfeeding women, illiterate
- Other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sir run run shaw hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
B
Bingjun Bai, MD
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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