Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients … (NCT07149090) | Clinical Trial Compass
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
South Korea61 participantsStarted 2025-11-11
Plain-language summary
To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma
✓. Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)
✓. PD-L1 combined positive score of ≥5 based on the 28-8 assay
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
✓. Age \> 19 years at time of study entry
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Life expectancy of \> 4 months
✓. Body weight \> 30kg
Exclusion criteria
✕. Disease progression within 6 months after completion of adjuvant chemotherapy.
✕. Participation in another clinical study with an investigational product during the last 2 weeks
✕. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
What they're measuring
1
Phase 1b part: Recommend phase 2 dose(RP2D)
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
2
Phase II part: 6 month progression-free survival (PFS) rate
. 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
✕. Major surgical procedure within 28 days prior to the first dose