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A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer

NCT05769725 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-03-15

No results posted yet for this study

Summary

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

Conditions

  • Serplulimab,Gastric Cancer, Adjuvant Therapy

Interventions

DRUG

Serplulimab

Serplulimab, 4.5mg/kg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

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.

DRUG

S1

Tegafur-gimeracil-oteracil potassium: 50mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769725 on ClinicalTrials.gov