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Herzuma-capecitabine/Cisplatin for Gastric Cancer

NCT03588533 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-07-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trastuzumab

* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle) * Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks

DRUG

Capecitabine

\- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks

DRUG

Cisplatin

\- Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks

Sponsors & Collaborators

  • Celltrion

    collaborator INDUSTRY

  • Sung Yong Oh

    lead OTHER

Principal Investigators

  • Sung Yong Oh, MD · Dong-A University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-10
Primary Completion
2019-08-31
Completion
2021-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588533 on ClinicalTrials.gov