Actively Recruiting
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Led by Sir Run Run Shaw Hospital · Updated on 2025-06-26
170
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.
CONDITIONS
Official Title
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who strongly wish to preserve the anus and agree to receive neoadjuvant therapy
- Male or female aged 18 to 75 years
- Diagnosed with low rectal cancer within 10 cm from tumor edge to anal verge, clinical stage cT3-4bN0/+M0 with lymph nodes limited to mesorectum
- Histologically confirmed rectal adenocarcinoma with genetic testing showing MSI-L or MSS, or pMMR by immunohistochemistry
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1
- No prior anti-tumor therapy, immunotherapy, or pelvic radiation
- Laboratory tests show no contraindications to radiotherapy, chemotherapy, and immunotherapy
- Signed informed consent form
You will not qualify if you...
- History of malignant tumors other than rectal cancer
- Presence of distant metastases before enrollment
- Positive internal or external iliac lymph nodes on MRI or CT
- Obstruction, perforation, or bleeding requiring emergency surgery
- Severe concomitant diseases with estimated survival time of 5 years or less
- Allergy to any therapy components
- Use of immunosuppressive or systemic hormone therapy for immunosuppression within 1 month before therapy
- Participation in other experimental drug trials or immunotherapy within 30 days before screening
- Conditions like alcoholism, drug abuse, serious illnesses requiring combination therapy, or severe lab abnormalities
- Congenital or acquired immune deficiency including HIV infection
- Vulnerable groups such as mentally ill, cognitively impaired, critically ill, minors, pregnant or lactating women, or illiterate
- Other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
Z
Zhangfa Song, M.D, PH.D
CONTACT
C
Cheng Cai, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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