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Herzuma-capecitabine/Cisplatin for Gastric Cancer (HERZUMA-GC)

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ClinicalTrials.gov Identifier: NCT03588533
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Celltrion
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2018
First Posted Date  ICMJE July 17, 2018
Last Update Posted Date July 17, 2018
Actual Study Start Date  ICMJE June 10, 2018
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Adverse event [ Time Frame: up to 12 months ]
Adverse event related with Herzuma
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Overall response rate [ Time Frame: up to 6 months ]
    complete response+partial response by RECIST
  • Progression free survivals (PFS) [ Time Frame: up to 12 months ]
    PFS
  • All adverse events [ Time Frame: up to 12 months ]
    All adverse events during treatment
  • Overall survivals (OS) [ Time Frame: up to 12 months ]
    OS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Herzuma-capecitabine/Cisplatin for Gastric Cancer
Official Title  ICMJE Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients.
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.

Detailed Description

Stomach cancer is the fifth largest cancer in the world, with an estimated 723,000 patients each year, and cancer-related deaths being the third leading cause. In contrast to the decline in the West, the Far East Asia, including South Korea, showed a high prevalence of cancer. In 2014, 29,854 new cases of cancer were reported in Korea. This is the second most important cancer in terms of incidence and the third in cancer related mortality.

The 5 year survival rate has increased to 74 % due to increased early detection of stomach cancer, but in the case of metastatic stomach cancer, the rate of gastric cancer is about one-third of the total number of stomach cancer cases, resulting in poor outcomes. Treatment is 5-fluorouracil, Oxaliplatin, Irinotecan, Epirubicin , Docetaxel, etc. based on platinum or non-platinum. 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 in progression free survival (18.6 months vs. 17.1 months) and total overall survival (13.8 months vs. 11.1 months) (hazard ratio 0.74 ; 95 % confidential interval(CI) 0.60-0.91 ; p=0.0046) Trastuzumab was first used for HER-2 and breast cancer, and in three weeks of treatment, it is recommended to perform an induction phase of 8 mg/kg of 90 min and then a maintenance phase of 6mg/kg of 30min to 60min infusion. However, clinical research and data analysis are required because of concerns of toxic expression due to short-term injection. The phase I study of the maintenance 30 minutes toxicity was performed in breast cancer, and there was little difference from 60 minutes of injection in a 250ml or 100ml solution or new toxic event.

Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In the phase I pharmacodynamics study, same the results with trastuzumab were reported. Biosimilar use was approved based on the results of a phase III clinical study on breast cancer. A double-blind, random assignment test was conducted on 549 HER-2 positive breast cancer patients comparing the validity and stability of Trastuzumab. The primary goal was to achieve a postoperative pathologic complete remission in 46.8 % of Herzuma® compared to 50.4% of trastuzumab. In addition, the secondary goal of "overall response rate " and "pharmacodynamics" showed the same results as the Trastuzumab control group.

Biosimilar Herzuma® licensed through breast cancer study also can be used in HER-2 overexpressed stomach cancer. However, there has not been a study on the effects and side effects of the drug.

So in this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
  • 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
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER-2 Positive Gastric Cancer
  • Metastatic Cancer
Intervention  ICMJE
  • Drug: Trastuzumab
    • Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
    • Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks
    Other Name: Herzuma
  • Drug: Capecitabine
    - Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
    Other Name: Xeloda
  • Drug: Cisplatin
    - Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks
Study Arms  ICMJE Experimental: Herzuma-capecitabine/cisplatin(XP)
  • 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
Interventions:
  • Drug: Trastuzumab
  • Drug: Capecitabine
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sung Yong Oh, MD +82512402808 drosy@dau.ac.kr
Contact: Enhee Choi, RN +82512405044 dongahicrc8@naver.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03588533
Other Study ID Numbers  ICMJE DAUHIRB-18-121
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sung Yong Oh, Dong-A University Hospital
Study Sponsor  ICMJE Sung Yong Oh
Collaborators  ICMJE Celltrion
Investigators  ICMJE
Principal Investigator: Sung Yong Oh, MD Dong-A University Hospital
PRS Account Dong-A University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP