HER-2 Positive Gastric CancerPhase 4NCT02380131
Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
A Phase 4 study testing Oxaliplatin plus Capecitabine and Herceptin in people with HER-2 Positive Gastric Cancer and Liver Metastasis, run by Hebei Medical University at 1 site in China.
Trial summary
Stage I：preoperative therapy Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER-2 Positive Gastric Cancer, Liver Metastasis
- What is being tested?
- Oxaliplatin plus Capecitabine and Herceptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2017
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Pathological tissue were gastric cancer by gastric and liver biopsy.
- 2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).
- 3.gastric cancer with liver metastasis were not able to resectable lesions.
- 4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
- 5.ECOG performance status 0-1.
- 6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.
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- 8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
- 10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
- 11.The operation can complete the D2 operation(LNM≥15).
- 12.LVEF≥50%
Who cannot join
- 1. Patients with other extrahepatic metastasis Include peritoneal metastasis.
- 3. Patients with other malignancy in 5 years.
- 4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
- 5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
- 6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
- 7.Patients have history of organ transplantation.
- 8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
- 9.Patients combined antitumor drug outside the research program.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Internal Medicine-Oncology
Shijiazhuang, Hebei, 050011
Qun Zhao, Doctor, +8613930162111, zhaoqun516@126.com
Qun Zhao, Dortor
About this study
Official title: Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
Stage I：preoperative therapy
- Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
- Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;
Read the detailed description
The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.
- Conditions
- HER-2 Positive Gastric Cancer, Liver Metastasis
- Being tested
- Oxaliplatin plus Capecitabine, Herceptin
- Keywords
- XELOX, Herceptin, Potentially Resectable Gastric Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin plus CapecitabineDrug
Also called Oxaliplatin plus capecitabine other names:XELOX.
A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.
HerceptinDrug
Also called Trastuzumab
Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Herceptin | Experimental | drug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.
To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis Receives: Drug: Oxaliplatin plus Capecitabine; Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
Measured: 2 years
Secondary outcomes (1)
Objective response rate (ORR)
Measured: within 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
- Investigators
- Qun Zhao, Doctor, Principal investigator, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380131
- Sponsor's protocol ID
- Alien-Craft 0002
- Status last verified
- Feb 2015
- First submitted
- 8 Oct 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT02380131
- Acronym / sponsor ID
- Alien-Craft 0002
- Conditions
- HER-2 Positive Gastric Cancer, Liver Metastasis
- Keywords
- XELOX, Herceptin, Potentially Resectable Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- 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.
Stage I：preoperative therapy
- Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
- Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;
Detailed description
The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herceptin | Experimental | Drug: Oxaliplatin plus Capecitabine, Drug: Herceptindrug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles. To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Pathological tissue were gastric cancer by gastric and liver biopsy.
- 2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).
- 3.gastric cancer with liver metastasis were not able to resectable lesions.
- 4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
- 5.ECOG performance status 0-1.
Key exclusion criteria (8 listed)
- 1. Patients with other extrahepatic metastasis Include peritoneal metastasis.
- 3. Patients with other malignancy in 5 years.
- 4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
- 5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
- 6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
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 |
|---|---|---|
| Oxaliplatin plus CapecitabineAlso: Oxaliplatin plus capecitabine other names:XELOX.A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles. | Drug | Herceptin |
| HerceptinAlso: TrastuzumabHerceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles. | Drug | Herceptin |
Primary outcome
progression-free survival(PFS)
Time frame: 2 years
1 secondary outcome
Objective response rate (ORR)
Time frame: within 3 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Qun Zhao, Doctor principal investigator
Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxaliplatin plus Capecitabine and Herceptin in people with HER-2 Positive Gastric Cancer and Liver Metastasis, run by Hebei Medical University at 1 site in China.
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 10 inclusion and 8 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 5 Mar 2015. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: 2 years). 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 5 Mar 2015.