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New cocktail of drugs shows promise against stomach cancer in early trial

NCT ID NCT04745988

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a combination of lenvatinib, pembrolizumab, and chemotherapy (FLOT) can shrink stomach tumors before surgery and prevent recurrence afterward. It involves 43 adults with untreated, non-metastatic stomach cancer. The main goal is to see how many patients have a major reduction in tumor cells after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenvatinib, pembrolizumab, docetaxel, oxaliplatin, levofolinate
What this could lead to
If successful, this combination could shrink tumors before surgery and improve outcomes for gastric cancer patients.
What could go wrong
This is a small, early-phase trial with no control group. The drug combination may cause significant side effects and may not prove effective in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 43 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have gastric and gastroesophageal junction adenocarcinoma 2. Untreated and cT2-4 and/or cN+ without evidence of metastatic disease 3. Patients at least 20 years of age on the day of providing consent. 4. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group. 5. Patients with adequate organ function at the time of enrollment as defined below: * Neutrophil count ≥1500mm3 * Platelet count ≥10 × 100,000/mm3 * Hemoglobin (Hb) ≥ 9.0 g/dL, * Total bilirubin ≤1.5 mg/dL * AST (GOT) and ALT (GPT) ≤ 100 IU/L * Creatinine ≤1.5 mg/dL * Urinary protein : It satisfies one of the following (if any of the inspection criteria are satisfied, other examination may not be carried out) (i) urinary protein (test paper method) is 2+ or less (ii) Urine Protein Creatinine (UPC) ratio \<3.5 (iii) 24-hour urine protein was measured, urinary protein ≦ 3500 mg * International normalized ratio (INR) ≤ 1.5 6. Patients who not received a blood transfusion within 14 days of registration. 7. Patients have recovered adverse events associated with radiation and surgical operation as pretreatment to Grade 1 or less or baseline or less with CTCAE v5.0 excluding stable symptoms. However, adverse events with stable symptoms even with Grade 2 or higher excluded. 8. Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence or use of a male condom plus partner use of contraceptive method \[an intrauterine device or hormone releasing system, a contraceptive implant and an oral contraceptive\]) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment. 9. Patients capable of taking oral medication. 10. Patients who provided written informed consent to be subjects in this study. Exclusion Criteria: 1. Patients who have undergone surgical treatment and radiotherapy within 2 weeks before enrollment. 2. Patients with hypertension that is difficult to control (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents. 3. Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment. 4. Patients with a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction. 5. Patients have an addigional active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months. 6. Patients have severe (hospitalization required) complications (intenstinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, mental disease, cerebrovascular disease etc). 7. Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment. 8. Is infected with active hepatitis B (defined as HBs antigen positive) or hepatitis C. 9. Patients with a history of human immunodeficiency virus (HIV). 10. Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 11. Patients who are administered live vaccines \<30 days before the initiation of treatment with the investigational drug. 12. Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease. 13. Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy \<14 days before enrollment. 14. Patients have serious non-healing wound, ulcer, or bone fracture. 15. Females who are pregnant or breastfeeding. 16. Patients have no intention to comply with the protocol or cannot comply. 17. Patients were judged unsuitable as subject of this study by investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Cancer Center Hospital East

    Kashiwa, Chiba, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.