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

Conditions

• Gastric Cancer Stage III

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Camrelizumab — DRUG
  Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
• Oxaliplatin — DRUG
  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.
• Tegafur gimeracil oteracil potassium capsule — DRUG
  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.

Study Details

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.

Key Dates

Start date

Sep 9, 2020

Status verified

Sep 2024

Primary completion

Dec 29, 2023

Completion

Mar 29, 2026

Study Design

Enrollment

52 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Camrelizumab and chemotherapy
  Participants receive camrelizumab 200 mg intravenously (IV) on the first day (q3w), then oxaliplatin 130 mg/m\^2, IV on the first day (q3w), and 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. Three weeks as a course of treatment, a total of 8 courses.

Primary Outcome Measure

The incidences and types of adverse events [ Time Frame: 9 months ]