Clinical trial · Interventional
Herzuma-capecitabine/Cisplatin for Gastric Cancer
Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients.
- 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)
Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months. According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Positive Gastric Cancer | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Herzuma-capecitabine/cisplatin(XP)
- description
- * Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle) * Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks * Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks * Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks
- interventionNames
- Drug: Trastuzumab
- Drug: Capecitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Adverse event
- timeFrame
- up to 12 months
- description
- Adverse event related with Herzuma
Secondary outcomes (4)
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Gastric or gastroesophageal junction adenocarcinoma 2. HER-2 immuno-histochemical (IHC) (3 +) stain or her-2 silver in situ hybridization(SISH)/fluorescence in situ hybridization(FISH) (+) 3. Herzuma® -capecitabine/cisplatin combination regimen is planned as a first line treatment Exclusion Criteria: 1. Other type of cancer of Gastric or gastroesophageal junction adenocarcinoma (e.g., lymphoma, sarcoma) 2. HER-2 (0/1+) in IHC or her-2 SISH/FISH (-). 3. Patients who previously performed stomach cancer treatment as a palliative setting.
References
Publications (0)
Data not yet available