gallbladder carcinoma
Conditions
Interventions
Group A:Treating with Gemcitabine and GEMOX
Group B:Treating with Fluorouracil and GEMOX
Group C:Treating with Cis-platinum and GEMOX
Group D:Treating with Gemcitabine and FOLFIRINOX
Group E:Treating with Fluorouracil and FOLFIRINOX
Group F:Treating with Cis-platinum and FOLFIRINOX
Group G:Treating with Gemcitabine
Group H:Treating with Fluorouracil
Group I:Treating with Cis-platinum
Sponsors
Renji 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 suitable for radical surgery or have progressed R1 resection or palliative surgery; 4. Adequate fresh tumor tissue for genome sequencing and IHC; 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 = 3 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 80 x 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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The size and quantity of organoids;Half maximum inhibitory concentration (IC50);Progression free survival;Overall survival;Objective Response Rate;Clinical Benefit Response; | — |
Countries
China
Contacts
Public ContactLiu Yingbin
Renji Hospital
Outcome results
None listed