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Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

NCT05360277 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-12

No results posted yet for this study

Summary

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

Conditions

  • Metastatic Colorectal Cancer，NED

Interventions

DRUG

Tislelizumab + Capecitabine

Tislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.

OTHER

Best supportive care

Best supportive care

Sponsors & Collaborators

  • Yanhong Deng

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2025-02-28
Completion
2027-11-30

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 NCT05360277 on ClinicalTrials.gov