A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

Sponsor
RenJi Hospital
Study ID
NCT04152889
Phase
PHASE2
Status
Unknown

Conditions

  • Gastric Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
  • S-1 — DRUG
    Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.
  • Docetaxel — DRUG
    Docetaxel: 40 mg/m\^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.

Study Details

To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.

Key Dates

Start date
Apr 14, 2020
Status verified
Apr 2020
Primary completion
Apr 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+chemotherapy

Primary Outcome Measure

DFS [ Time Frame: 1YEARS ]

Central Contacts