Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03588533
Status:
UNKNOWN
Last Update Posted:
2018-07-17
First Post:
2018-07-01
Brief Title:
Herzuma-capecitabineCisplatin for Gastric Cancer
Sponsor:
Sung Yong Oh
Organization:
Dong-A University Hospital
Study Overview
Official Title:
Safety and Efficacy Evaluation of Capecitabine Cisplatin and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERZUMA-GC
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 resultsHerzuma 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
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 resultsHerzuma 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 723000 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 29854 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-2HER-2 And Using of Trastuzumab reported better results in progression free survival 186 months vs 171 months and total overall survival 138 months vs 111 months hazard ratio 074 95 confidential intervalCI 060-091 p00046 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 mgkg of 90 min and then a maintenance phase of 6mgkg 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 468 of Herzuma compared to 504 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
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-2HER-2 And Using of Trastuzumab reported better results in progression free survival 186 months vs 171 months and total overall survival 138 months vs 111 months hazard ratio 074 95 confidential intervalCI 060-091 p00046 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 mgkg of 90 min and then a maintenance phase of 6mgkg 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 468 of Herzuma compared to 504 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None