advanced bile duct
Conditions
Interventions
1:tube tumor cell vesicles encapsulated-methotrexate by PTCD/ENBD drainage
Sponsors
Nankai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) patients with a diagnosis of biliary tract carcinoma with obstructive jaundice by pathological or clinical imaging; (2) patients in accordance with conventional clinical treatment plan for surgery and systemic chemotherapy efficacy or recurrence, or patients for their own reasons for the implementation of routine treatment, giving up routine clinical treatment; (3) stable vital signs, Karnofsky score (Karnofsky) = 60 points; (4) aged 18-85 years; (5) bone marrow hematopoietic function is normal, no bleeding tendency (INR PLT > 80, 4*10^9/L, renal function (BUN, Cr) BUN index does not exceed 1.5 times the upper limit of normal, Cr normal liver function, AST and ALT is less than or equal to 10 times normal the upper limit (ULN), liver function Child grade A or B; (6) the ECG is generally normal, and the blood glucose level is normal.
Exclusion criteria
Exclusion criteria: (1) women who are nursing, pregnant or are preparing for pregnancy; (2) allergic constitution and a variety of drug allergies; (3) combined with cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system, and other serious diseases, as well as the subjects; (4) patients with severe infection; (5) three months to the other clinical trials; (6) the researchers considered unfit for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time;Overall survival time;median survival time;Changes of bile duct obstruction;Tumor objective response rate;Disease control rate;KPS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood tumor markers;liver function;Immune index; | — |
Countries
China
Contacts
Public ContactHui Zhang
Outcome results
None listed