Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
NCT ID: NCT03772132
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2016-07-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy
The patients wil receive conventional chemotherapy FORFIRINOX
mutation and signal pathway activation status analysis Drug: FORFIRINOX
Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy
Interventions
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mutation and signal pathway activation status analysis Drug: FORFIRINOX
Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy
Eligibility Criteria
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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
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. - Page 5 of 5 \[DRAFT\] -
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Eastern Hepatobiliary Surgery Hospital
OTHER
Huashan Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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liu yingbin
head of general surgery department，xin hua Hospital Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigators
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yingbin liu, PHD
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xinhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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yingbin liu
Role: primary
Other Identifiers
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DLY20181206
Identifier Type: -
Identifier Source: org_study_id