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OncoMatch/Clinical Trials/NCT05769725

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

Is NCT05769725 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Serplulimab and Docetaxel for serplulimab,gastric cancer, adjuvant therapy.

Phase 2RecruitingRenJi HospitalNCT05769725Data as of May 2026

Treatment: Serplulimab · Docetaxel · S1To 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.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Biomarker criteria

Required: PD-L1 (CD274) overexpression (CPS ≥ 5)

PD-L1 + CPS ≥ 5

Required: MSH2 deficient mismatch repair

dMMR

Required: MSH6 deficient mismatch repair

dMMR

Required: MLH1 deficient mismatch repair

dMMR

Required: PMS2 deficient mismatch repair

dMMR

Required: MSI MSI-H

MSI-H +

Required: EBV positive

EBV+

Disease stage

Required: Stage III

Excluded: Stage DISTANT METASTASIS

Stage III gastric cancer confirmed by pathology; Distant metastasis was diagnosed by CT /MR/ EUS [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment

Cannot have received: radiotherapy

No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment

Cannot have received: immunotherapy

No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment

Lab requirements

Blood counts

hemoglobin ≥ 90g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L

Liver function

AST or ALT ≤ 2.5 ULN; ALP ≤ 2.5×ULN

The baseline blood routine and biochemical indexes of the selected patients should meet the following standards: hemoglobin ≥ 90g / L; absolute neutrophil count ≥ 1.5 × 10^9 / L; platelet count ≥ 100 × 10^9 / L; AST or ALT ≤ 2.5 ULN; ALP ≤ 2.5×ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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