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New hope for stomach cancer: drug cocktail shows promise in early trial

NCT ID NCT07529613

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a mix of three drugs—trastuzumab deruxtecan (a targeted therapy), nivolumab (an immunotherapy), and chemotherapy—in 30 people with untreated HER2-low stomach or gastroesophageal junction cancer. The goal was to first find a safe dose and then see how well it shrinks tumors. While not a cure, the approach aims to control the disease and improve outcomes for a type of cancer that has few treatment options.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

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. Historical confirmation of adenocarcinoma of the gastric, gastroesophageal junction, or esophagus is considered by the investigator or subinvestigator to be unresectable advanced or recurrent. 2. HER2 low expression: IHC1+, or IHC2+ and ISH negative \[FISH or DISH method\] in HER2 test of the primary lesion or metastatic lesion. 3. Having one or more measurable disease as specified in RECIST Guideline version 1.1. 4. Systemic treatment is untreated (local radiation and surgical treatment is acceptable). 5. Age at the date of informed consent is 20 years or older. 6. ECOG Performance status (PS) of 0 or 1. 7. Has LVEF \>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment. 8. Has a corrected QT interval (QTc) =\< 470 ms in females, or QTc =\< 450 ms in males based on a 12-lead ECG screening within 28 days before enrollment (allowed on the same day of the week). \[Fridericia's correction is recommended\] 9. The most recent laboratory value within 14 days before enrollment meets all of the following. (Examinations on the same day of the week 2 weeks prior to the date of enrollment are allowed.) (1)Absolute Neutrophil count =\< 1,500/mm3 (2)Hemoglobin =\< 9.0 g/dL (3)Platelet count =\< 100,000/mm3 (4)Total bilirubin =\< 1.5 mg/dL (5)AST(GOT) =\< 100 IU/L =\< 200 IU/L in the presence of hepatic involvement (6)ALT(GPT) =\< 100 IU/L =\< 200 IU/L in the presence of hepatic involvement (7)Creatinine =\< 1.5 mg/dL (8)PT(INR) \< 1.8 and aPTT \< 60 seconds 10. Has adequate treatment washout period before enrollment (allowed on the same day of the week), defined as: i. Surgery with general anesthesia: \>= 4 weeks ii. Radiotherapy: \>= 4 weeks (including palliative stereotactic body radiation therapy to the chest; palliative stereotactic body radiation therapy to other than the chest \>= 2 weeks; abdominal vertebral bodies should be included in the abdomen). iii. Chloroquine and hydroxychloroquine: \>= 15 days 11. No blood transfusion was performed within 7 days before registration. (Transfusions on the same day of the week prior to the day of enrollment are allowed.) 12. Female of childbearing potential have a negative pregnancy test within 7 days before enrollment (allowed on the same day of the week). Male and Female of childbearing potential agree to contraception for a period (4 months for male and 7 months for Female) from informed consent to the last dose of study drug. 13. Written informed consent of participation in the study has been obtained from the patient. Exclusion Criteria: 1. Has a prior chemotherapy for unresectable advanced or recurrent gastric/esophagogastric junction/esophageal adenocarcinoma. (Note: Patients are eligible if they have received prior preoperative or postoperative adjuvant therapy. However, treatment must have been completed at least 6 months prior to enrollment and progression must have occurred at least 6 months after completion of treatment). 2. Metastases to the central nervous system have been identified. (Only if CNS involvement is clinically suspected, cerebral CT scanning or MRI confirmation is mandatory at the time of screening.). 3. Has a medical history of myocardial infarction or congestive heart failure (New York Heart Association Classes II-IV) within 6 months before enrollment, corresponding to the \*\*troponin levels diagnosed as myocardial infarction as defined by the \*manufacturer within 28 days before enrollment (allowed on the same day), unstable angina, or any serious arrhythmia requiring treatment. \*: Manufacturer refers to a testing company used by a study implementation institution. \*\*: Enrollment is allowed if a subject exceeds ULN, if the subject is examined and myocardial infarction can be excluded. 4. Active cancer that requires aggressive treatment, such as chemotherapy or operation 5. Has serious (hospitalized) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes mellitus that is difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disorders, cerebrovascular disorders, etc.) 6. Grade 1 or residual adverse effects of prior therapy that have not resolved to baseline (excluding hair loss). Note:Participants with Grade2 chronic toxicity (Defined as no worse than Grade 2 for at least 3 months prior to enrollment and manageable with standard therapy) who are considered by the investigator to have treatment-related toxicity are eligible for enrollment. * Chemotherapy-Induced Neuropathy * Malaise 7. Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment. 8. Has any of the following infections: * HBs antigen positive * HBs antibody or HBc antibody and HBV-DNA positive * Active hepatitis C (e.g., if HCV RNA is detected qualitatively) Patients who are HBsAg positive but who have achieved HBV DNA level \< 1.3 log IU/mL (2.1 log copies/mL) after treatment with antiviral drugs such as NAs, are eligible for the study. 9. HIV infection has been documented. 10. Lung diseases are defined as: * Has a history of non-infectious interstitial lung disease or pneumonitis that required treatment, has interstitial lung disease or pneumonitis, or these lung diseases cannot be ruled out by radiographic examination before enrollment. * Severe pulmonary impairment (e.g., pulmonary embolism within 3 months prior to enrollment, serious bronchial asthma, severe COPD, restrictive pulmonary disease, or pleural effusion). * Lung-related autoimmune or connective tissue or inflammatory diseases (e.g., rheumatoid arthritis, Sjogren's syndrome, or sarcoidosis) with clinically severe pulmonary risks. * Has history of pneumonectomy. 11. Has history of concomitant autoimmune disease or chronic or recurrent autoimmune disease. 12. Administration of systemic adrenocortical hormones (except prophylactic administration for tests or allergic reactions, and temporary use for the purpose of reducing edema associated with radiotherapy) or immunosuppressants is required, or has received these treatments within 14 days before enrollment in the study. 13. Has unhealed wounds, ulcers, or fractures. 14. If you have uncontrolled acute systemic infection that requires Infusion intravenous antibiotic, antiviral, or antifungal drug. 15. If you have received a live attenuated vaccine (mRNA vaccine or replication-defective adenovirus vaccine is not regarded as live attenuated vaccine) within 30 days before the initial administration. 16. If patients are a pregnancy or breastfeeding patient. 17. Patients who do not take appropriate contraceptive measures during the study and contraceptive period 18. Severe hypersensitivity to the active ingredient or additive of the study drug has been confirmed. 19. Has history/complications of severe hypersensitivity reactions to other monoclonal antibodies. 20. Unwilling or unable to comply with any of implementation matters stipulated in the study implementation protocol or any of the instructions of the physician. 21. The investigator or sub investigator considered it ineligible for the study.

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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, 277-8577, Japan

More trials for these conditions

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