Actively Recruiting
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 Locally Advanced Rectal Cancer
Led by Tao Zhang · Updated on 2026-05-13
444
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a national multicenter, prospective randomized, placebo- 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.
CONDITIONS
Official Title
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 Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their family members agree to participate and sign the informed consent form
- Age between 18 and 75 years, male or female
- Histologically confirmed locally advanced rectal adenocarcinoma
- Immunohistochemistry and/or genetic testing confirming pMMR/MSS status
- Tumor inferior margin located 10 cm or less from the anal verge
- ECOG performance status score of 0 or 1
- No prior anti-tumor treatments for rectal cancer including radiotherapy, chemotherapy, or surgery
- No contraindications for surgery
- Laboratory values meeting specified criteria for blood counts, liver and kidney function, coagulation, and urinary protein levels
You will not qualify if you...
- Patients with MSI-H/dMMR locally advanced rectal cancer
- Previous receipt of any form of immunotherapy including immune checkpoint inhibitors or immune cell therapy
- Presence of any other disease, condition, substance abuse history, or laboratory abnormality that may affect safety, consent, compliance, or safety evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Z
Zhenyu Lin, MD
CONTACT
T
Tao Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here