Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab [Herceptin] | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: trastuzumab [Herceptin]
Primary outcomes (1)
- measure
- Median Progression Free Survival (PFS)
- timeFrame
- Baseline up to PD or death (maximum up to 22 months)
- description
- The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters \[mm\]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of "last tumor measurement," "last date of study drug treatment," or "last follow-up." The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy * Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) * HER2 positive tumor (primary tumor or metastasis * ECOG Performance status 0, 1 or 2 * Life expectancy of at least 3 months Exclusion Criteria: * Previous chemotherapy for advanced or metastatic disease less than 6 month before study start * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study) * Patients with active (significant or uncontrolled) gastrointestinal bleeding * Residual relevant toxicity resulting from previous chemotherapy * Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
References
Publications (0)
Data not yet available