gallbladder carcinoma
Conditions
Interventions
Group A:treating with Afatinib and Nivolumab
Group B:treating with Afatinib
Group C:treating with GEMOX
Sponsors
Xinhua Hospital affiliated to Shanghai Jiaotong University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old, Asian; 2. Stable vital signs, KPS=60; 3. 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; 4. Adequate fresh tumor tissue for genome sequencing and IHC; harboring mutations or abnormal activation of ERBB family signal pathway components; 5. At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1; 6. Life expectancy of more than 12 weeks; 7. 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; 8. Volunteer for this study, have written informed consent and have good Patient compliance; 9. Female patients of childbearing potential and their mates agree to avoid pregnancy.
Exclusion criteria
Exclusion criteria: 1. Have recieved following treatment before this study: (1) Anti-tumor chemotheropy or molecular target therapy as palliative treatment; (2) lesions have been treated by irradiation; (3) participate in other theraputic or interventional clinical trials; 2. Have central nervous system metastasis; 3. 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; 4. Have symptomatic ascites and need for treatment; 5. 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(SBP>160mmHg or DBP>100mmHg); (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; 6. Have known be allergic to target medicines involved in this study, gemcitabine or oxaliplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Objective Response Rate;Disease Control Rate;Clinical Benefit Response; | — |
Contacts
Public ContactLiu Yingbin
Xinhua Hospital affiliated to Shanghai Jiaotong University, School of Medicine
Outcome results
None listed