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Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

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ClinicalTrials.gov Identifier: NCT02836847
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
RenJi Hospital
Eastern Hepatobiliary Surgery Hospital
Huashan Hospital
Information provided by (Responsible Party):
liu yingbin, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma of the Extrahepatic Bile Duct Gallbladder Cancer Procedure: biological test Drug: GEMOX Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib Phase 2

Detailed Description:
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study.These information will be used to recommend target therapy which may be more likely to result in a beneficial response.Patients will receive target anti-tumor agents according to the result of genomic and proteomic profiling.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
 Procedure: biological test
mutation and signal pathway activation status analysis

Drug: GEMOX
Conventional chemotherapy:gemcitabine and oxaliplatin

Drug: Cetuximab
Drug: Trastuzumab
Drug: Gefitinib
Drug: Lapatinib
Drug: Everolimus
Drug: Sorafenib
Drug: Crizotinib
GEMOX
The patients wil receive conventional chemotherapy(GEMOX).
 Procedure: biological test
mutation and signal pathway activation status analysis

Drug: GEMOX
Conventional chemotherapy:gemcitabine and oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: up to 1 year ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 2 years ]
  2. Objective Response Rate [ Time Frame: up to 1 year ]
    Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment, consistent with RECIST version 1.1 criteria for solid tumors.

  3. Disease Control Rate [ Time Frame: up to 1 year ]
    Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors.

  4. percentage of patients with Clinical Benefit Response [ Time Frame: up to 1 year ]

    Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.

    Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese；
  • Stable vital signs, KPS≥60;
  • Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
  • Adequate fresh tumor tissue for genome sequencing and immuno-histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
  • At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
  • Life expectancy of more than 12 weeks;
  • Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥80×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
  • Volunteer for this study, have written informed consent and have good Patient compliance;
  • Female patients of childbearing potential and their mates agree to avoid pregnancy.

Exclusion Criteria:

  • Have received following treatment before this study:

    1. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
    2. lesions have been treated by irradiation;
    3. participate in other therapeutic or interventional clinical trials.
  • Have central nervous system metastasis;
  • History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
  • Have symptomatic ascites and need for treatment;

  • Have serious concurrent illness including, but not limited to

    1. uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);
    2. ongoing or active serious infection;
    3. uncontrolled diabetes mellitus;
    4. psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
    5. HIV infection;
    6. other serious illness considered not suitable for this study by investigators.
  • be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836847


Contacts
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Contact: liu yingbin, PHD +86 13918803900 laoniulyb@163.com

Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: yingbin liu    13918803900    laoniulyb@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
RenJi Hospital
Eastern Hepatobiliary Surgery Hospital
Huashan Hospital
Investigators
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Principal Investigator: liu yingbin, PHD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: liu yingbin, head of general surgery department，xin hua Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02836847    
Other Study ID Numbers: DLY201507
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cholangiocarcinoma
Gallbladder Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Trastuzumab
 Cetuximab
Everolimus
Sorafenib
Lapatinib
Gefitinib
Crizotinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action