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Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

NCT05245474 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-01-10

No results posted yet for this study

Summary

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

Conditions

  • Locally Advanced Rectal Cancer

Interventions

COMBINATION_PRODUCT

Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)

Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • BeiGene

    collaborator INDUSTRY

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Zhongtao Zhang · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-03-01
Completion
2029-09-01

Countries

  • China

Study Locations

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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 NCT05245474 on ClinicalTrials.gov