Anti-HER2 therapy plus chemotherapy after surgery for HER2-positive stomach cancer
Official title: A Randomized, Controlled, Open-Label, Multicenter Clinical Trial Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression
Run by Xijing Hospital · NCT07788196 · Data updated 2026-11-12
In people with stage IB-II HER2-positive gastric cancer who have had surgery, this study tests whether adding trastuzumab to standard chemo helps more than chemo alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, trastuzumab |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07788196 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with surgically resected, HER2-positive stage IB-II gastric or gastroesophageal junction adenocarcinoma, adequate organ function, and planned adjuvant therapy.
✕Probably not a fit
Patients unlikely to benefit include those without HER2 overexpression or those intolerant to trastuzumab or chemotherapy due to comorbidity or safety concerns.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized Phase 2 trial enrolling about 120 adults with HER2-positive gastric or gastroesophageal junction cancer after tumor removal. Participants are randomized 1:1 to receive trastuzumab with standard adjuvant chemotherapy or to receive standard chemotherapy alone, with regimens varying by stage (tegafur for stage IB; SOX or XELOX for stage II). The trial is led by Xijing Hospital and involves 11 centers total. Outcomes of interest include treatment tolerance and cancer control, using standard adjuvant therapy protocols as the comparator. Eligibility requires confirmed histology, adequate organ function, ECOG 0-2, and confirmed HER2 positivity with completed surgical resection.
Why it matters
Potential benefit: If successful, patients may have improved cancer control and survival with the addition of trastuzumab to adjuvant chemotherapy.
How similar studies have gone: Previous research in HER2-positive gastric cancer supports benefits of HER2-targeted therapy when combined with chemotherapy, but data in the adjuvant setting remain limited and this study will add targeted evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Yongzhan Nie
- Email: zhengrong4956@163.com
- Phone: +86 198 2975 8242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.