cholangiocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18-80 years; 2.Cholangiocarcinoma was diagnosed by preoperative pathological examinarion or clincal examinarion; 3.ECOG score between 0-2 points; 4.The expected survival time was more than 12 weeks 5.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; 6.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; 7.Volunteer for this study, have written informed consent.
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 cholangiocarcinoma 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) HIV infection; (5) psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol; (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;Objective Response Rate;Clinical Benefit Response; | — |
Countries
China