OncoMatch/Clinical Trials/NCT07149090
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
Is NCT07149090 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Lenvatinib for stomach neoplasm.
Treatment: Lenvatinib — To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) combined positive score ≥5 (28-8 assay) (CPS ≥5)
PD-L1 combined positive score of ≥5 based on the 28-8 assay
Disease stage
Metastatic disease required
metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: adjuvant chemotherapy
Exception: disease progression within 6 months after completion
Disease progression within 6 months after completion of adjuvant chemotherapy
Cannot have received: investigational product
Exception: within last 2 weeks
Participation in another clinical study with an investigational product during the last 2 weeks
Cannot have received: concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Exception: hormonal therapy for non-cancer-related conditions allowed
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC > 1500 per mm3; Platelet count ≥100 (or 75) x 10^9/L (>75,000 per mm3)
Kidney function
Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine CL >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection
Liver function
Serum bilirubin ≤1.5 x institutional ULN; AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN
Adequate normal organ and marrow function as defined below: * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC) 1.5 x (> 1500 per mm3) * Platelet count ≥100 (or 75) x 109/L (>75,000 per mm3) * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN * Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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