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NOT YET RECRUITING
NCT05231850
PHASE2

A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

Summary

10%-15% of early-stage colon cancers harbour either deficient mismatch repair (dMMR), microsatellite instability high (MSI-H) is characterised by high tumour mutational burden and increased lymphocytic infiltrate. Metastatic dMMR colon cancers are highly sensitive to immune checkpoint inhibition.The MSI phenotype is associated with a better prognosis than MSS in stage II and III CRCs. However, there are conflicting data about the benefit of adjuvant chemotherapy in this group of patients. We are conducting a single arm study phase II trial to determine if the anti-PD-1 antibody Tislelizumab improves disease-free survival (DFS) in patients with high risk stage II and stage III dMMR/MSI-H colon cancer.

Official title: A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With High-risk Stage Ⅱ and Stage Ⅲ Colon Cancer and Deficient Mismatch Repair or Microsatellite Instability.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-03-01

Completion Date

2027-09-01

Last Updated

2022-02-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tislelizumab

All eligible patients receive received 200 mg Tislelizumab intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.