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Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.

NCT04911517 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-23

No results posted yet for this study

Summary

Long course radiotherapy plus neoadjuvant chemotherapy followed by resection total mesorecta excision has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tislelizumab, an anti-PD1(programmed death 1) humanized IgG4 (Immunoglomin G4) monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China.

The aim of This NCRT-PD-1-LARC trial is to evaluate the efficacy and safety of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision for LARC. This NCRT-PD-1-LARC trial will be a prospective, multicenter and phase Ⅱ clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision. It will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 10cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by total mesorecta excision 6-12 week after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes.

Conditions

  • Colorectal Neoplasms

Interventions

COMBINATION_PRODUCT

long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations

long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer

Sponsors & Collaborators

  • Hangzhou New Horizon Health Technology Co., Ltd.

    collaborator UNKNOWN

  • BeOne Medicines

    collaborator INDUSTRY

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • People's Hospital of Tianjin

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • [email protected] Yao, Dr. · Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-12-31
Completion
2024-12-31

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 NCT04911517 on ClinicalTrials.gov