Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites

NCT07149090 | Recruiting Phase 1

• 1 other identifier: AMC2501
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STOMACH NEOPLASM; Gastric Cancer; Gastric Cancer Adenocarcinoma Metastatic

Keywords

Stomach Neoplasms; Gastric cancer; Lenvatinib; Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Phase 1b part: Recommend phase 2 dose(RP2D)

  Phase 1b part: will follow a traditional 3+3 dose-escalation design. Dose-limiting toxicities (DLTs) will be assessed after the first 3 subjects are enrolled. If no DLTs are observed among the initial 3 subjects, the dose level will be considered the recommended phase 2 dose (RP2D). If 1 of the initial 3 subjects experiences a DLT, 3 additional subjects will be enrolled at the same dose level (for a total of 6 subjects). If ≤1 of 6 subjects experience a DLT, the dose level will be defined as the RP2D. Up to 12 subjects may be enrolled in the Phase 1b part.

  At the end of Cycle 1 (each cycle is 21 days)

• Phase II part: 6 month progression-free survival (PFS) rate

  6 month progression-free survival (PFS) rate

  At 6 months

Study Arms (1)

Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)

EXPERIMENTAL

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

Description: Lenvatinib: 12 mg (for body weight ≥ 60 kg) or 8 mg (for body weight \< 60 kg) per oral once daily * Dose level 1: 8mg per oral once daily (for \<60kg) 12mg per oral once daily (for ≥ 60kg) * Dose level 2: 4mg per oral once daily (for \<60kg) 8mg per oral once daily (for ≥ 60kg) Nivolumab: 360 mg administered intravenously every 3 weeks Chemotherapy(Oxaliplatin+Capecitabine) every 3 weeks * Capecitabine 1000 mg/m² per oral twice daily on Days 1-14 * Oxaliplatin 130 mg/m² administered intravenously on Day 1

Also known as: Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)

Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No existing neuropathy
• 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

You may not qualify if:

• 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
• 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
• Unable to take medication orally
• Gastrointestinal bleeding
• Impaired bowel absorption
• History of allogenic organ transplantation
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
• History of another primary malignancy except for
• Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• History of active primary immunodeficiency

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Hyung-Don Kim

CONTACT

82-2-3010-0236; kimhdmd@amc.seoul.kr

Jaewon Hyung

CONTACT

82-2-3010-1464; musicine123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 29, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)