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NCT04515615
PHASE2

Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

Sponsor: Yu jiren

View on ClinicalTrials.gov

Summary

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion rate.

Official title: A Multi-center, Phase II Study to Evaluate Safety and Efficacy of Adjuvant Chemotherapy With Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin and Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2020-09-09

Completion Date

2026-03-29

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab

Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

DRUG

Oxaliplatin

Oxaliplatin: 130 mg/m\^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle.

DRUG

Tegafur gimeracil oteracil potassium capsule

Tegafur gimeracil oteracil potassium capsule: 80 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for a cycle.

Locations (4)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Taizhou Hospital

Taizhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China