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NOT YET RECRUITING
NCT06238167
PHASE2

Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

Summary

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III gastric cancer (including esophagogastric junction cancer) after D2 dissection.

Official title: A Single Arm, Phase 2 Clinical Study Evaluating the Efficacy and Safety of Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-04-01

Completion Date

2028-12-31

Last Updated

2024-02-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tislelizumab

Tislelizumab, 200mg Q3W, max 16 cycles.

DRUG

S-1 therapy

S1 d1-14 bid (\< 1.25m\^2 40mg, 1.25m\^2-1.5m\^2 50mg, ≥ 1.5m\^2 60mg), followed by 7 days off (Q3W, max 16 cycles).

DRUG

low dose SOX therapy

Oxaliplatin: 78mg/m\^2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).