NCT07469306

Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• 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 plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Detailed description

In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Modified Short-course radiotherapy	Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
RADIATION	Long-course radiotherapy	Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f
DRUG	Oxaliplatin	130 mg/m²,d1, q3w ,4 cycles
DRUG	Capecitabine	1000 mg/m, d1-14,bid,q3w, 4 cycles
DRUG	Tislelizumab	200mg,d1,q3w,4 cycles
DRUG	Capecitabine	825 mg/m² ,BID ,on radiation days
DRUG	Tislelizumab	200mg,d1,q3w,3 cycles

Timeline

• Start date: 2026-08-10
• Primary completion: 2027-08-10
• Completion: 2027-09-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

3 sites across 1 country: China