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NOT YET RECRUITING
NCT07900061
PHASE3

Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Rectal Cancer

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX works to treat pMMR/MSS locally advanced mid-to-low rectal cancer. It will also learn about the safety of this treatment. The main question it aims to answer is: Does node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX prolong survival and improve the quality of life of participants? Researchers will compare node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX to standard short-course radiotherapy combined with CAPOX to see if it works to treat pMMR/MSS locally advanced mid-to-low rectal cancer. Participants will randomized allocated to accept one of the two treatments. After 4 cycles chemotherapy plus tislelizumab or not, participants will be managed with total mesorectal excision (TME), local excision, or a watch-and-wait strategy based on their clinical response and will undergo long-term follow-up.

Official title: Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Locally Advanced Mid-to-low Rectal Cancer: An Open-label, Multi-center, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-10-25

Completion Date

2034-12

Last Updated

2026-10-28

Healthy Volunteers

No

Conditions

Interventions

RADIATION

node-sparing modified short-course radiotherapy

Study participants receive modified short-course radiotherapy to the rectum for 5 days. The radiation field covers the primary rectal tumor region, excluding regional lymphatic drainage areas, with a total radiation dose of 25 Gy (5 Gy per fraction × 5 fractions). On Day 8 after radiotherapy initiation, participants receive combination therapy with CAPOX (Oxaliplatin 130 mg/m², ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w) and tislelizumab (200 mg, ivgtt on Day 1; q3w). Treatment cycles are repeated every 3 weeks for a total of 4 cycles.

RADIATION

standard short-course radiotherapy

Study participants receive standard short-course radiotherapy for 5 days. On Day 8 after radiotherapy initiation, participants receive CAPOX (Oxaliplatin 130 mg/m², ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w). Treatment cycles are repeated every 3 weeks for a total of 4 cycles.