Herzuma-capecitabine/Cisplatin for Gastric Cancer

NCT03588533 | Unknown Phase 2

• 1 other identifier: DAUHIRB-18-121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

HER-2 Positive Gastric Cancer; Metastatic Cancer

Keywords

HER-2 Positive; Gastric or gastroesophageal adenocarcinoma; Herzuma

Outcome Measures

Primary Outcomes (1)

• Adverse event

  Adverse event related with Herzuma

  up to 12 months

Secondary Outcomes (4)

• Overall response rate

  up to 6 months

• Progression free survivals (PFS)

  up to 12 months

• All adverse events

  up to 12 months

• Overall survivals (OS)

  up to 12 months

Study Arms (1)

Herzuma-capecitabine/cisplatin(XP)

EXPERIMENTAL

* 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

Drug: Trastuzumab; Drug: Capecitabine; Drug: Cisplatin

Interventions

Trastuzumab DRUG

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

Also known as: Herzuma

Herzuma-capecitabine/cisplatin(XP)

Capecitabine DRUG

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

Also known as: Xeloda

Herzuma-capecitabine/cisplatin(XP)

Cisplatin DRUG

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

Herzuma-capecitabine/cisplatin(XP)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastric or gastroesophageal junction adenocarcinoma
• HER-2 immuno-histochemical (IHC) (3 +) stain or her-2 silver in situ hybridization(SISH)/fluorescence in situ hybridization(FISH) (+)
• Herzuma® -capecitabine/cisplatin combination regimen is planned as a first line treatment

You may not qualify if:

• Other type of cancer of Gastric or gastroesophageal junction adenocarcinoma (e.g., lymphoma, sarcoma)
• HER-2 (0/1+) in IHC or her-2 SISH/FISH (-).
• Patients who previously performed stomach cancer treatment as a palliative setting.

Sponsors & Collaborators

• Sung Yong Oh: lead
• Celltrion: collaborator

Study Sites (1)

Dong-A University Hospital

Busan, 49201, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Trastuzumab; Capecitabine; Cisplatin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sung Yong Oh, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Yong Oh, MD

CONTACT

+82512402808; drosy@dau.ac.kr

Enhee Choi, RN

CONTACT

+82512405044; dongahicrc8@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pricipal Investigator

Model Details: * Herzuma 8mg/kg loading over 90min (1st cycle) * 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

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 17, 2018
• Study Start: June 10, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2021
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

KR (1)