Can an antibody boost chemotherapy to stop early stomach cancer from returning?

NCT ID NCT07788196

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether adding the targeted antibody trastuzumab to standard chemotherapy after surgery can help prevent early-stage (IB-II) HER2-positive gastric cancer from coming back. About 120 adults who have had their tumor removed will be randomly assigned to receive either chemotherapy alone or chemotherapy plus trastuzumab for six cycles. The main goal is to see if the combination improves disease-free survival over five years, with overall survival also tracked.

What this could mean

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

Active substance
Trastuzumab (an anti-HER2 antibody) combined with standard chemotherapy
What this could lead to
If successful, this could establish a new standard adjuvant treatment for early-stage HER2-positive gastric cancer, potentially improving long-term survival after surgery.
What could go wrong
This is a phase 2 trial with a modest sample size, so results may not be definitive. Trastuzumab can cause heart problems and infusion reactions, and the added benefit over chemotherapy alone is not yet proven.

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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 120 people

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

Started

Jul 2026

Expected to finish

Dec 2030

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

18 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: * Age ≥ 18 years; Open to all genders; * Patients with a definitive histopathological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and an ECOG score ≤ 2; * Gastric cancer or gastroesophageal junction cancer with TNM stage IB-II; * HER-2-positive (IHC 3+ or IHC 2+ with amplification confirmed by FISH/SISH/CISH); * Tumor resection has been completed, and adjuvant therapy is planned postoperatively; * Adequate organ function; participants must meet the following laboratory criteria: * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days; * Platelet count ≥ 100 × 10⁹/L, without a blood transfusion within the past 14 days; * Hemoglobin \> 9 g/dL, without a blood transfusion or the use of erythropoietin within the past 14 days; * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; * Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min; * Normal coagulation function, defined as an International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN; * Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be enrolled provided that total T3 (or FT3) and FT4 are within the normal range; * Cardiac enzyme levels are within the normal range (participants with isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive assessment may also be enrolled); * Voluntary participation in the study and signing of an informed consent form prior to study initiation. Exclusion Criteria: * Other malignant tumors of the stomach; * Received, prior to screening, or is scheduled to receive during the trial any anticancer therapy other than the chemotherapy regimen specified in the protocol (e.g., radiation therapy, targeted therapy, immunotherapy); * Has or has had a malignant tumor in any other part of the body (except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or other tumors that have been surgically cured and have not recurred for at least 5 years); * Presence of any severe or uncontrolled systemic disease, such as: * Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) Class ≥ 2; * Significant and symptomatic, difficult-to-control abnormalities in rhythm, conduction, or morphology on a resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation; * Any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; * Poorly controlled blood pressure (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg); * A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease; * Active pulmonary tuberculosis; * Active or uncontrolled infection requiring systemic treatment; * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; * Liver disease, such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis; * Poorly controlled diabetes (fasting blood glucose (FBG) \> 10 mmol/L); * Patients with urine protein ≥++ on urinalysis and confirmed 24-hour urine protein quantification \> 1.0 g; * Patients with psychiatric disorders who are unable to comply with treatment; * Patients currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months; * Patients with known allergies to the medications used in this study; * Patients deemed unsuitable for participation in this clinical trial by the 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.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • The First Affiliated Hospital of Air Force Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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