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NOT YET RECRUITING
NCT06118658
PHASE2

Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations

Sponsor: China Medical University, China

View on ClinicalTrials.gov

Summary

Objective of this study to evaluate 1-year disease-free survival in patients with dMMR/MSI-H or POLE/POLD1 gene mutations with gastric or esophagus-gastric junctional adenocarcinoma or colorectal adenocarcinoma after chemotherapy-sequential tiralizumab adjuvant radical resection (based on RECIST v1.1 criteria).

Official title: A Single-arm, Open, Multicenter Phase II Study of Chemotherapy-sequential Tislelizumab Adjuvant Therapy After Radical Resection in Patients With Gastric or Colorectal Adenocarcinoma With dMMR/MSI-H or POLE/POLD1 Mutations

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-11-01

Completion Date

2026-12-31

Last Updated

2023-11-07

Healthy Volunteers

Yes

Interventions

DRUG

tislelizumab

About 30 patients who underwent radical gastrectomy or enterectomy with gastric adenocarcinoma or esophagogastric junction adenocarcinoma with postoperative pathological stage III or intestinal adenocarcinoma with postoperative pathological stage T1-3N2M0 or T4N+M0(American Joint Committee on Cancer,AJCC 8th Edition Cancer Stage) were scheduled to be enrolled after fully informed and signed informed consent Qualified subjects were selected to receive the standard XELOX or SOX regimen selected by the investigators according to the disease and postoperative pathology of the subjects for 4 cycles, followed by the sequential treatment of monotherapy tislelizumab (200mg,Q3W, IV infusion,4 cycles) starting from 4-6 weeks after surgery, with a maximum of 12 weeks Safety assessments such as ECOG physical examination of vital signs and laboratory tests will be performed regularly during treatment

Locations (1)

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China