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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT07149090 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior adjuvant chemotherapy, investigational product, concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 combined positive score ≥5 (28-8 assay) is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages