RecruitingPhase 2NCT05769725

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

A Study to Evaluate 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)

Sponsor

RenJi Hospital

Enrollment

70 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Serplulimab,Gastric Cancer, Adjuvant Therapy

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding serplulimab (an immunotherapy drug) to standard chemotherapy (docetaxel + S-1) as adjuvant treatment after surgery can reduce the risk of recurrence in patients with stage IIIC gastric (stomach) cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage III gastric cancer confirmed by pathology - Your cancer has certain biomarker features: PD-L1 CPS ≥ 5, MSI-H, EBV-positive, or dMMR - You have not received any prior anti-tumor treatment (chemotherapy or radiation) before surgery - You are in good overall health (ECOG 0–1) **You may NOT be eligible if...** - You have received pre-surgery chemotherapy or radiation - Your tumor does not have the required biomarker features - You are pregnant or unwilling to use contraception during and after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

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

DRUGDocetaxel

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.

DRUGS1

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

Locations(1)

Zhang Zizhen

Shanghai, China

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NCT05769725