RecruitingPhase 3NCT07113275

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

A National Multicenter, Randomized, Placebo-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 Locally Advanced Rectal Cancer


Sponsor

Tao Zhang

Enrollment

444 participants

Start Date

May 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Capecitabine, a drug called HLX10, and others for people with immunotherapy, radiotherapy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONShort-course radiotherapy

Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.

RADIATIONLong-course radiotherapy

Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.

DRUGCapecitabine

1000mg/m2, bid, po, d1-14,q3w

DRUGOxaliplatin

130mg/m2, ivgtt, d1,q3w

DRUGHLX10

300mg, ivgtt, q3w

PROCEDURETME surgery

The surgery was performed 1 week after the end of neoadjuvant therapy.

DRUGHLX10 placebo

300mg, ivgtt, q3w


Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

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NCT07113275


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