STOMACH NEOPLASMPhase 1/2NCT07149090
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
A Phase 1/2 study testing Lenvatinib in people with STOMACH NEOPLASM and Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- STOMACH NEOPLASM, Gastric Cancer, Gastric Cancer Adenocarcinoma Metastatic
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2025to 30 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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:
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Who cannot join
- 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
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- 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
- Active infectious disease
- Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice)
- Hepatitis B (known positive HBV surface antigen (HBsAg) result)
- Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)
- Human immunodeficiency virus (positive HIV 1/2 antibodies)
- Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the final dose of lenvatinib.
- Known allergy or hypersensitivity to the investigational drug or any of its components.
- Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Hyung-Don Kim, 82-2-3010-0236, kimhdmd@amc.seoul.kr
Jaewon Hyung, musicine123@gmail.com
About this study
Official title: A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.
To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Read the detailed description
Gastric cancer is the 4th leading cause of cancer-related mortality and the 5th most common malignancy worldwide. The past decade has seen significant progress in first-line systemic chemotherapy for patients with advanced gastric cancer. Immune checkpoint inhibitor (ICI)-based chemotherapy has become the standard first-line treatment since the demonstration of improved overall survival (OS) due to nivolumab plus chemotherapy in the Checkmate-649 study. Subsequent phase 3 trials have also demonstrated the positive impact of adding ICI to chemotherapy on survival. However, a proportion of patients still show poor survival outcomes with first-line ICI plus chemotherapy, highlighting an unmet need to improve treatment outcomes in such patients.
While patients with microsatellite instability (MSI)-high gastrointestinal cancers exhibit favorable outcomes with ICIs, MSI-high gastrointestinal cancers with peritoneal metastases and ascites exhibited highly unfavorable outcomes to ICI-based therapies. To this end, a research team analyzed the survival outcomes of gastric cancer patients treated with first-line nivolumab plus chemotherapy, finding that patients with peritoneal metastasis and grade ≥ 2 ascites had detrimental survival outcomes despite a high PD-L1 CPS (≥5). Ascites VEGF level was reportedly high in patients with a large amount of malignant ascites, supporting the concept that anti-VEGF therapies are promising for treating gastric cancer patients with peritoneal metastasis.
Lenvatinib is a potent multiple RTKi that selectively inhibits VEGF receptors, VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4), FGFR1-4, PDGFRα, c-KIT, and RET, which is approved for use in various cancer types, including hepatocellular carcinoma. Among known kinase inhibitors in clinical use, lenvatinib is one of the only inhibitors currently labeled with a mechanism of action as an inhibitor of not only VEGFRs but also FGFRs, both of which are currently believed to be very important for tumor angiogenesis.
It is hypothesized that the addition of lenvatinib to nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites could improve survival outcomes for these patients. A prospective phase Ib/II trial has been designed to investigate the efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
- Being tested
- Lenvatinib
- Keywords
- Stomach Neoplasms, Gastric cancer, Lenvatinib, Advanced Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)
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
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin) | Experimental | Not described Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start11 Nov 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STOMACH NEOPLASMStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Don Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149090
- Sponsor's protocol ID
- AMC2501
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.
- ClinicalTrials.gov ID
- NCT07149090
- Acronym / sponsor ID
- AMC2501
- Keywords
- Stomach Neoplasms, Gastric cancer, Lenvatinib, Advanced Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Detailed description
Gastric cancer is the 4th leading cause of cancer-related mortality and the 5th most common malignancy worldwide. The past decade has seen significant progress in first-line systemic chemotherapy for patients with advanced gastric cancer. Immune checkpoint inhibitor (ICI)-based chemotherapy has become the standard first-line treatment since the demonstration of improved overall survival (OS) due to nivolumab plus chemotherapy in the Checkmate-649 study. Subsequent phase 3 trials have also demonstrated the positive impact of adding ICI to chemotherapy on survival. However, a proportion of patients still show poor survival outcomes with first-line ICI plus chemotherapy, highlighting an unmet need to improve treatment outcomes in such patients.
While patients with microsatellite instability (MSI)-high gastrointestinal cancers exhibit favorable outcomes with ICIs, MSI-high gastrointestinal cancers with peritoneal metastases and ascites exhibited highly unfavorable outcomes to ICI-based therapies. To this end, a research team analyzed the survival outcomes of gastric cancer patients treated with first-line nivolumab plus chemotherapy, finding that patients with peritoneal metastasis and grade ≥ 2 ascites had detrimental survival outcomes despite a high PD-L1 CPS (≥5). Ascites VEGF level was reportedly high in patients with a large amount of malignant ascites, supporting the concept that anti-VEGF therapies are promising for treating gastric cancer patients with peritoneal metastasis.
Lenvatinib is a potent multiple RTKi that selectively inhibits VEGF receptors, VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4), FGFR1-4, PDGFRα, c-KIT, and RET, which is approved for use in various cancer types, including hepatocellular carcinoma. Among known kinase inhibitors in clinical use, lenvatinib is one of the only inhibitors currently labeled with a mechanism of action as an inhibitor of not only VEGFRs but also FGFRs, both of which are currently believed to be very important for tumor angiogenesis.
It is hypothesized that the addition of lenvatinib to nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites could improve survival outcomes for these patients. A prospective phase Ib/II trial has been designed to investigate the efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin) | Experimental | Drug: Lenvatinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)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 | Drug | Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin) |
Primary outcome
Phase 1b part: Recommend phase 2 dose(RP2D)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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.
Phase II part: 6 month progression-free survival (PFS) rate
Time frame: At 6 months
6 month progression-free survival (PFS) rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenvatinib in people with STOMACH NEOPLASM and Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyung-Don Kim (82-2-3010-0236, kimhdmd@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b part: Recommend phase 2 dose(RP2D) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.