Actively Recruiting
A National Multicenter, Randomized, Placebo-Controlled Phase III Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Led by Tao Zhang · Updated on 2026-05-13
444
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for locally advanced rectal cancer in this national, multicenter, randomized, placebo-controlled Phase III clinical trial. The study aims to evaluate whether combining immunotherapy with total neoadjuvant therapy (TNT) offers better benefits than long-course radiotherapy followed by TNT alone. It also compares the effectiveness and side effects of different radiotherapy types when combined with immunotherapy under TNT. Participants are assigned to one of three groups: one receives short-course radiotherapy (SCRT) followed by immunotherapy and chemotherapy; another receives long-course radiotherapy (LCRT) with concurrent chemotherapy plus immunotherapy and chemotherapy; and the third group receives LCRT with concurrent chemotherapy followed by TNT chemotherapy and a placebo instead of immunotherapy. Immunotherapy or placebo is given via intravenous infusion every three weeks for six cycles. After neoadjuvant therapy, patients may undergo surgery or opt for a watch-and-wait approach if they achieve complete remission. During the study, participants undergo dynamic monitoring including MRI and blood tests to track tumor response and minimal residual disease, especially for tumors close to the anal verge. Researchers assess outcomes such as event-free survival over three years, complete response rates, overall survival, and treatment side effects using standardized criteria. The trial includes follow-up visits and safety evaluations over several years to monitor long-term effects and treatment results.
CONDITIONS
Brief 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 informed consent
- 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 located 10 cm or less from the anal verge
- ECOG performance status of 0 to 1
- No prior anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, or surgery
- No contraindications for surgery
- Laboratory values within specified limits including white blood cells, neutrophils, platelets, hemoglobin, liver and kidney function, and coagulation tests
- Urinary protein less than 2+ or 24-hour urinary protein excretion less than 1 gram at baseline
You will not qualify if you...
- Patients with MSI-H/dMMR locally advanced rectal cancer
- Prior receipt of any form of immunotherapy, including immune checkpoint inhibitors or cell therapy
- Presence of any other disease, condition, or history that may affect safety, consent, compliance, or safety assessment as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week for short-course radiotherapy or approximately 5.5 weeks for long-course radiotherapy
Participants receive either short-course radiotherapy over 5 consecutive days or long-course radiotherapy delivered daily 5 days per week for approximately 5.5 weeks.
5 daily visits for short-course radiotherapy or daily visits 5 days per week for approximately 5.5 weeks for long-course radiotherapy
Duration - Approximately 18 weeks (6 cycles of 3 weeks each)
Participants receive immunotherapy (HLX10 or placebo) intravenously every 3 weeks for 6 cycles, combined with neoadjuvant chemotherapy consisting of oxaliplatin infusion on Day 1 and oral capecitabine twice daily on Days 1-14 per 3-week cycle.
6 visits every 3 weeks for immunotherapy and chemotherapy administration
Duration - Surgery performed approximately 1 week after neoadjuvant therapy completion
Participants undergo total mesorectal excision (TME) surgery or may opt for a watch and wait strategy if clinical complete remission is achieved after neoadjuvant therapy.
1 visit for surgery
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
T
Tao Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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