Can an antibody boost chemotherapy to stop early stomach cancer from returning?
NCT ID NCT07788196
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Air Force Military Medical University
RECRUITINGXi'an, Shaanxi, 710032, China
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Other studies related to the condition(s) this trial covers.
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- New drug cocktail aims to tackle tough stomach cancer
- New drug under Real-World watch for tough stomach cancer
- New hope for stomach cancer: targeted drug combo trial launches