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Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma | Clinical Trials | Clareo Health

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

NCT03768375•Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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 FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
•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;
+2 more criteria

Locations (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 1, 2016

Primary Completion Date

December 30, 2020

Completion Date

December 30, 2021

Last Updated

December 7, 2018

Enrollment

150

ESTIMATED participants

Conditions

Cholangiocarcinoma of the Extrahepatic Bile DuctGallbladder Cancer

Interventions

conventional chemotherapy(FORFIRINOX) combined with target agents

BIOLOGICAL

conventional chemotherapy(FORFIRINOX)

BIOLOGICAL

Contacts

yingbin liu, PHD

CONTACT

+86 13918803900 laoniulyb@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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