Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2018-06-10
2021-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
* 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
TREATMENT
NONE
Study Groups
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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
Trastuzumab
* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
* Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks
Capecitabine
\- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
Cisplatin
\- Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks
Interventions
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Trastuzumab
* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
* Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle\~ ) every 3 weeks
Capecitabine
\- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
Cisplatin
\- Cisplatin 60\~100mg/m2 i.v. D1 every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. HER-2 (0/1+) in IHC or her-2 SISH/FISH (-).
3. Patients who previously performed stomach cancer treatment as a palliative setting.
20 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Sung Yong Oh
OTHER
Responsible Party
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Sung Yong Oh
Pricipal Investigator
Principal Investigators
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Sung Yong Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Locations
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Dong-A University Hospital
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DAUHIRB-18-121
Identifier Type: -
Identifier Source: org_study_id
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