NCT07113275

A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer

A National Multicenter, Randomized Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 435 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a national multicenter, prospective randomized controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.

Detailed description

This study is a national multicenter, prospective randomized controlled phase III clinical trial, with the following objectives: 1. For patients with high-risk LARC, to determine whether the efficacy of TNT combined with immunotherapy is superior to that of the treatment mode of LCRT followed by TNT; 2. To compare the differences in efficacy and toxicity between long-course radiotherapy and short-course radiotherapy under the mode of TNT combined with immunotherapy. For precision management of patients with cCR post-neoadjuvant therapy, dynamic MRD monitoring was implemented, including baseline and follow-up testing for patients having tumors ≤5 cm from the anal verge.

Conditions

• Rectal Cancer
• Total Neoadjuvant Therapy
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
RADIATION	Short-course radiotherapy	Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
RADIATION	Long-course radiotherapy	Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.
DRUG	Capecitabine	1000mg/m2, bid, po, d1-14,q3w
DRUG	Oxaliplatin	130mg/m2, ivgtt, d1,q3w
DRUG	HLX10	300mg, ivgtt, q3w
PROCEDURE	TME surgery	The surgery was performed 1 week after the end of neoadjuvant therapy.
DRUG	HLX10 placebo	300mg, ivgtt, q3w

Timeline

• Start date: 2026-02-11
• Primary completion: 2028-01-01
• Completion: 2028-12-31
• First posted: 2025-08-08
• Last updated: 2026-02-12

Locations

1 site across 1 country: China