Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer

Last updated: June 21, 2025
Sponsor: Sir Run Run Shaw Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Rectal Cancer

Digestive System Neoplasms

Colorectal Cancer

Treatment

node-sparing modified short-course radiotherapy

Oxaliplatin

standard short-course radiotherapy

Clinical Study ID

NCT06507371
SRRS-mRCA-III
  • Ages 18-75
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have a strong willingness to preserve the anus and are willing toreceive neoadjuvant therapy.

  2. Male or Female aged 18-75.

  3. Patients diagnosed with low rectal cancer within 10 cm from the lower edge of thetumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage iscT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.

  4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L orMSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6,and PMS2 are all positive.

  5. Eastern Cooperative Oncology Group (ECOG) score 0-1.

  6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvicradiation).

  7. Laboratory tests indicating no contraindications to radiotherapy, chemotherapy andimmunotherapy.

  8. Informed consent form signed.

Exclusion

Exclusion Criteria:

  1. Patients with a previous history of malignant tumors besides rectal cancer.

  2. Patients with distant metastases before enrollment.

  3. Patients with positive internal or external iliac lymph nodes are assessed by MRI orCT.

  4. Patients with obstruction, perforation, or bleeding that require emergency surgery.

  5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.

  6. Allergic to any component of the therapy.

  7. Patients who received immunosuppressive or systemic hormone therapy forimmunosuppressive purposes within 1 month prior to the initiation of therapy.

  8. Patients who have received any other experimental drug (including immunotherapy) orparticipated in another interventional clinical trial within 30 days beforescreening.

  9. Factors leading to study termination, such as alcoholism, drug abuse, other seriousillnesses (including psychiatric disorders) requiring combination therapy, andpatients with severe laboratory abnormalities.

  10. Patients with congenital or acquired immune deficiency (such as HIV infection).

  11. Vulnerable groups, including mentally ill, cognitively impaired, critically illpatients, minors, pregnant or lactating women, illiterate, etc.

  12. Other conditions that investigators consider not suitable for this study.

Study Design

Total Participants: 170
Treatment Group(s): 5
Primary Treatment: node-sparing modified short-course radiotherapy
Phase: 3
Study Start date:
July 29, 2024
Estimated Completion Date:
August 15, 2026

Connect with a study center

  • Sir Run Run Shao hospital

    Hanzhou, Zhejiang 310016
    China

    Active - Recruiting

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