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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 (Jun 2026). This Phase 2 trial studies sintilimab+metronomic PLOF for gastric cancer.

Phase 2RecruitingHuashan HospitalNCT06054906Data as of Jun 2026Location: China

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

Treatments studied

Other

sintilimab+metronomic PLOF

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.

Frequently asked questions

Is NCT06054906 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage CT3-4AN1-3M0 is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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