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Active, not recruiting Phase 3

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

NCT06507371 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-07-29
Last updated
2026-06-30

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

node-sparing modified short-course radiotherapyPD-1 antibodyCapecitabine →Oxaliplatin →standard short-course radiotherapy

node-sparing modified short-course radiotherapy: radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx

PD-1 antibody: PD-1 antibody (Tislelizumab): 200mg d1 q3w

Capecitabine: Capecitabine: 1000mg/m2 d1-14 q3w

Oxaliplatin: Oxaliplatin: 130mg/m2 d1 q3w

standard short-course radiotherapy: radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy. 2. Male or Female aged 18-75. 3. 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. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) score 0-1. 6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation). 7. Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy. 8. Informed consent form signed. 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 or CT. 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 for immunosuppressive purposes within 1 month prior to the initiation of therapy. 8. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening. 9. 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. 10. Patients with congenital or acquired immune deficiency (such as HIV infection). 11. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc. 12. Other conditions that investigators consider not suitable for this study.

Primary outcome measure(s)

  • pathological complete response (pCR) rate — within 10 days after completion of surgery
    Pathological complete response (pCR) rate

Trial sites (1)

FacilityCityRegionStatus
Sir Run Run Shao hospital Hanzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06507371 on ClinicalTrials.gov ↗ ← All trials in China