Status:
RECRUITING
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 sur...
Eligibility Criteria
Inclusion
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
- No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
- Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy.
- Informed consent form signed.
Exclusion
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
- Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
- Patients with congenital or acquired immune deficiency (such as HIV infection).
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
- Other conditions that investigators consider not suitable for this study.
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06507371
Start Date
July 29 2024
End Date
August 15 2026
Last Update
June 26 2025
Active Locations (1)
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1
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China, 310016