NCT06333769

Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer

A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer

Detailed description

In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Conditions

• Mid-low Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Short-course Radiotherapy	Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
DRUG	Tislelizumab	Tislelizumab：200mg，d1，q3w，2 cycles.
DRUG	Capecitabine	Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.
DRUG	Oxaliplatin	Oxaliplatin：130mg/m2, d1, q3w, 2 cycles

Timeline

• Start date: 2024-07-12
• Primary completion: 2025-08-10
• Completion: 2025-08-14
• First posted: 2024-03-27
• Last updated: 2025-08-15

Locations

3 sites across 1 country: China