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Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer

NCT05086627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-08-22

No results posted yet for this study

Summary

This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

Tislelizumab

Patients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin).

RADIATION

Short-course radiotherapy

Patients were treated with short-course neoadjuvant radiotherapy

DRUG

Capecitabine+Oxaliplatin

Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

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
2021-09-01
Primary Completion
2024-07-30
Completion
2024-08-20

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 NCT05086627 on ClinicalTrials.gov