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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

NCT07113275 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Rectal Cancer
  • Total Neoadjuvant Therapy
  • Radiotherapy
  • Immunotherapy

Interventions

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

Sponsors & Collaborators

  • Tao Zhang

    lead OTHER

Principal Investigators

  • Zhenyu Lin, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-01-01
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113275 on ClinicalTrials.gov