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OncoMatch/Clinical Trials/NCT06054906

Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer

Is NCT06054906 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies sintilimab+metronomic PLOF for gastric cancer.

Phase 2RecruitingHuashan HospitalNCT06054906Data as of May 2026

Treatment: sintilimab+metronomic PLOFTo evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) in resectable locally advanced gastric cancer.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Disease stage

Required: Stage CT3-4AN1-3M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic therapy

No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc.

Cannot have received: systemic proprietary Chinese medicines with antitumor indications or immunomodulatory drugs

Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug

Cannot have received: systemic glucocorticoid therapy or any other form of immunosuppressive therapy

Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.0x10^9/L; Platelets ≥ 80x10^9/L; Hemoglobin > 7g/dL

Kidney function

Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min

Liver function

Total bilirubin ≤ 1.5 x ULN (Total bilirubin > 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); AST, ALT ≤ 2.5×ULN

Cardiac function

Myocardial enzyme profile within normal range

Adequate organ function, must meet the following laboratory specifications: 8.1 Absolute neutrophil count (ANC) ≥ 1.0x10^9/L; 8.2 Platelets ≥ 80x10^9/L; 8.3 Hemoglobin > 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Total bilirubin > 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); 8.5 AST, ALT ≤ 2.5×ULN; 8.6 Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min; 8.7 INR or PT ≤ 1.5 times ULN; 8.8 TSH within normal range (Enrollment allowed if baseline TSH is outside normal range but FT4 is within normal range); 8.9 Myocardial enzyme profile within normal range

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

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