HER-2 Positive Gastric CancerPhase 2HERZUMA-GCNCT03588533
Herzuma-capecitabine/Cisplatin for Gastric Cancer
A Phase 2 study testing Trastuzumab, Capecitabine and Cisplatin in people with HER-2 Positive Gastric Cancer and Metastatic Cancer, run by Sung Yong Oh at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HER-2 Positive Gastric Cancer, Metastatic Cancer
- What is being tested?
- Trastuzumab, Capecitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jun 2018to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dong-A University Hospital
Busan, 49201
Sung Yong Oh, MD, +82512402808, drosy@dau.ac.kr
Enhee Choi, RN, +82512405044, dongahicrc8@naver.com
About this study
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.
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.
Read the 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.
- Conditions
- HER-2 Positive Gastric Cancer, Metastatic Cancer
- Being tested
- Trastuzumab, Capecitabine, Cisplatin
- Keywords
- HER-2 Positive, Gastric or gastroesophageal adenocarcinoma, Herzuma
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herzuma
- Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
- Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks
CapecitabineDrug
Also called Xeloda
- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
CisplatinDrug
- Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Adverse event related with Herzuma
Measured: up to 12 months
Secondary outcomes (4)
Overall response rate
complete response+partial response by RECIST
Measured: up to 6 months
Progression free survivals (PFS)
PFS
Measured: up to 12 months
All adverse events
All adverse events during treatment
Measured: up to 12 months
Overall survivals (OS)
OS
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start10 Jun 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung Yong Oh
- Sponsor type
- University, hospital or other
- Collaborators
- Celltrion
- Responsible party
- Sponsor-investigator, Sung Yong Oh, Dong-A University Hospital
- Investigators
- Sung Yong Oh, MD, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588533
- Sponsor's protocol ID
- DAUHIRB-18-121
- Acronym
- HERZUMA-GC
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03588533
- Acronym / sponsor ID
- HERZUMA-GC / DAUHIRB-18-121
- Conditions
- HER-2 Positive Gastric Cancer, Metastatic Cancer
- Keywords
- HER-2 Positive, Gastric or gastroesophageal adenocarcinoma, Herzuma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sung Yong OhUniversity, hospital or other
- Collaborators
- Celltrion
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Herzuma-capecitabine/cisplatin(XP) | Experimental | Drug: Trastuzumab, Drug: Capecitabine, Drug: Cisplatin* 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: Herzuma* Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle) * Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks | Drug | Herzuma-capecitabine/cisplatin(XP) |
| CapecitabineAlso: Xeloda- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks | Drug | Herzuma-capecitabine/cisplatin(XP) |
| Cisplatin- Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks | Drug | Herzuma-capecitabine/cisplatin(XP) |
Primary outcome
Adverse event
Time frame: up to 12 months
Adverse event related with Herzuma
4 secondary outcomes
Overall response rate
Time frame: up to 6 months
Progression free survivals (PFS)
Time frame: up to 12 months
All adverse events
Time frame: up to 12 months
Overall survivals (OS)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Oh, MD principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab, Capecitabine and Cisplatin in people with HER-2 Positive Gastric Cancer and Metastatic Cancer, run by Sung Yong Oh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Yong Oh, MD (+82512402808, drosy@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.