Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown

Phase 2

Conditions

Gallbladder Cancer

Cholangiocarcinoma of the Extrahepatic Bile Duct

Treatments

Biological: mutation and signal pathway activation status analysis Drug: FORFIRINOX

Study type

Interventional

Funder types

Other

Identifiers

NCT03772132

DLY20181206

Details and patient eligibility

About

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Full description

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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:
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.