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

NCT06118658 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-07

No results posted yet for this study

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).

Conditions

  • Gastric
  • Colorectal Adenocarcinoma

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

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06118658 on ClinicalTrials.gov