Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
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
1 other identifier
interventional
152
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 7, 2018
May 1, 2018
3.4 years
July 13, 2016
May 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
up to 1 year
Secondary Outcomes (4)
Overall survival
up to 2 years
Objective Response Rate
up to 1 year
Disease Control Rate
up to 1 year
percentage of patients with Clinical Benefit Response
up to 1 year
Study Arms (2)
target therapy
EXPERIMENTALThe patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
GEMOX
OTHERThe patients wil receive conventional chemotherapy(GEMOX).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Have received following treatment before this study:
- Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
- lesions have been treated by irradiation;
- 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
- 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);
- ongoing or active serious infection;
- uncontrolled diabetes mellitus;
- psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
- HIV infection;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Jiao Tong University School of Medicinelead
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Ruijin Hospitalcollaborator
- RenJi Hospitalcollaborator
- Eastern Hepatobiliary Surgery Hospitalcollaborator
- Huashan Hospitalcollaborator
Study Sites (1)
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
liu yingbin, PHD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of general surgery department，xin hua Hospital
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 19, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
May 7, 2018
Record last verified: 2018-05