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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    150
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 22 January 2021
tyrosine
carcinoma
cholangiocarcinoma
extrahepatic cholangiocarcinoma
gallbladder carcinoma
mates

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.

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.

Details
Condition Biliary neoplasm, Malignant neoplasm of gallbladder, Gallbladder Disease, Cholangiocarcinoma of the Extrahepatic Bile Duct, Gallbladder Carcinoma, Urothelial Tract Cancer, Gall Bladder Disorders, Gall Bladder Cancer, Biliary Tract Cancer, gallbladder cancer
Treatment conventional chemotherapy(FORFIRINOX) combined with target agents, conventional chemotherapy(FORFIRINOX)
Clinical Study IdentifierNCT03768375
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chinese
Stable vital signs, KPS60
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(ALT10upper limit of normal (ULN), AST10ULN, the Child-Pugh classification for class A or B, white blood cells310^9/L, neutrophils1.510^9/L, platelets8010^9/L , hemoglobin 90g/L, creatinine clearance rate60ml/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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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