NCT05479240

Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer--Randomized, Open, Multicenter Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of Neoadjuvant Chemoradiotherapy Combined With/without Tislelizumab in the Treatment of Locally Advanced Rectal Cancer

Conditions

• Immunotherapy

Interventions

Type	Name	Description
DRUG	Tislelizumab	Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 cycles.
DRUG	Capecitabine	Participants will receive Capecitabine, 1000mg/m2, day 1-14 of every 3 weeks for 6 cycles
DRUG	oxaliplatin	Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 6 cycles.
RADIATION	short-range radiotherapy	5\*5Gy，d1-d5

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-06-01
• Completion: 2028-06-01
• First posted: 2022-07-29
• Last updated: 2023-06-18