- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03768375
Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
December 6, 2018 updated by: liu yingbin, Shanghai Jiao Tong University School of Medicine
A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Study Overview
Status
Unknown
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yingbin liu, PHD
- Phone Number: +86 13918803900
- Email: laoniulyb@163.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200092
- Recruiting
- Xinhua Hospital
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Principal Investigator:
- yingbin liu, PHD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: target therap
The patients wil receive conventional chemotherapy(FORFIRINOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
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Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib
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EXPERIMENTAL: FORFIRINOX
The patients wil receive conventional chemotherapy(FORFIRINOX)
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conventional chemotherapy(FORFIRINOX)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: up to 1 year
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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.
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up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (ANTICIPATED)
December 30, 2020
Study Completion (ANTICIPATED)
December 30, 2021
Study Registration Dates
First Submitted
December 6, 2018
First Submitted That Met QC Criteria
December 6, 2018
First Posted (ACTUAL)
December 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2018
Last Update Submitted That Met QC Criteria
December 6, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLY201812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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