NCT06455124

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

Detailed description

A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included. Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor. They will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiation	Shor-course radiotherapy: 25Gy/5Fx
DRUG	PD-1 antibody	PD-1 antibody (Toripalimab): 240mg d1 q3w
DRUG	Capecitabine	Capecitabine: 1000mg/m2 d1-14 q3w
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2 d1 q3w

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-06-30
• Completion: 2029-12-30
• First posted: 2024-06-12
• Last updated: 2024-06-13

Locations

1 site across 1 country: China