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OncoMatch/Clinical Trials/NCT06519591

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

Is NCT06519591 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cadonilimab, LM-302, S-1, paclitaxel for gastric cancer stage iv.

Phase 2RecruitingRuijin HospitalNCT06519591Data as of May 2026

Treatment: Cadonilimab, LM-302, S-1, paclitaxelIn this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Biomarker criteria

Required: CLDN18 overexpression (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%)

Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%)

Required: HER2 (ERBB2) wild-type

her 2 (-)

Disease stage

Required: Stage IV

Metastatic disease required

Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: immunotherapy (PD-1, PD-L1, CTLA-4)

Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4

Cannot have received: targeted therapy (Claudin 18.2)

targeted therapy such as Claudin 18.2

Lab requirements

Blood counts

Adequate bone marrow function required

Kidney function

Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L [excluded]

Liver function

Adequate liver function required

Cardiac function

Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months [excluded]

Adequate bone marrow, liver, and renal functions. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months [excluded]. Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L [excluded]

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

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