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

Study Description

Brief 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.

Detailed Description: 1. Study population: participants with stage III gastric cancer confirmed by postoperative pathology according to American Joint Committee on Cancer (AJCC) / Union for International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging classification. 2. Sample size: single arm design was used in this study and 52 participants were estimated to be enrolled. 3. Research content: In this study, within 4-6 weeks after the completion of the operation, the participants were selected and qualified for this study, and were scheduled to receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then 130mg/m\^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day; ≥1.25 \~ \<1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a total of 8 courses, after treatment, safety visit and survival follow-up will be carried out. A total of 3 years follow-up time is scheduled since the first medication, and the frequency is once every 3-6 months within 2 years, and once every 6-12 months for the third year. 4. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will monitor carefully to determine whether or not they are within the expected range. The degree of AEs is evaluated according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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