Herzuma-capecitabine/Cisplatin for Gastric Cancer

• Status: Unknown status
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sung Yong Oh
• Collaborator: Celltrion
• Treatments: Capecitabine; Cisplatin; Trastuzumab

Criteria

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.