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

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

NCT ID: NCT06507371

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Antibodies

Conditions: Keywords:
node-sparing radiation
PD-1
MSS
short-course radioation

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: node-sparing modified short-course radiotherapy
Description: radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: PD-1 antibody
Description: PD-1 antibody (Tislelizumab): 200mg d1 q3w
Arm group label: Exploration Arm
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Capecitabine
Description: Capecitabine: 1000mg/m2 d1-14 q3w
Arm group label: Exploration Arm
Arm group label: Standard Arm
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Oxaliplatin: 130mg/m2 d1 q3w
Arm group label: Exploration Arm
Arm group label: Standard Arm
Arm group label: Treatment Arm

Intervention type: Radiation
Intervention name: standard short-course radiotherapy
Description: radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx
Arm group label: Exploration Arm
Arm group label: Standard Arm

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.

Criteria for eligibility:
Criteria:
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) 0-1. 6. No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation). 7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN; 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 with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma. 8. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy. 9. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening. 10. 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. 11. Patients with congenital or acquired immune deficiency (such as HIV infection). 12. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc. 13. Other conditions that investigators consider not suitable for this study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sir Run Run Shao hospital

Address:
City: Hanzhou
Zip: 310016
Country: China

Status: Recruiting

Contact:
Last name: Zhangfa Song, Dr

Phone: +86 13867421652
Email: songzhangfa@zju.edu.cn

Investigator:
Last name: Zhangfa Song, doctor
Email: Principal Investigator

Start date: July 1, 2024

Completion date: August 15, 2026

Lead sponsor:
Agency: Sir Run Run Shaw Hospital
Agency class: Other

Source: Sir Run Run Shaw Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06507371