Advanced biliary tract tumor
Conditions
Interventions
High matching group, low matching group:Nil
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. Patients with stable vital signs and KPS >= 60; 3. Patients who are not suitable for radical operation (R0) after histopathological or cytological diagnosis, or patients with non radical surgery (R1), late stage of palliative surgery, or patients with recurrent and metastatic malignant tumor of biliary tract; 4. Patients who can obtain enough fresh tumor tissue for multi omic sequencing and immunohistochemical detection; 5. According to RECIST version 1.1 evaluation criteria, at least one measurable and evaluable objective lesion (patients with the longest diameter of target lesion >= 10 mm in spiral CT examination; the shortest diameter >= 15 mm if only lymph node metastasis); 6. Patients with an expected survival time of more than 12 weeks; 7. In patients with liver function AST and alt 3 x 10^9 / L, absolute count of granulocyte >= 1.5 x 10^9 / L; platelet >= 75 x 10^9 / L; hemoglobin >= 90 g / L; creatinine clearance rate >= 60 ml / min; total bilirubin <= 3 times upper limit of normal value (ULN); 8. The patients who voluntarily participated in the study and signed the informed consent form, if the subjects could not read or sign, they should sign the informed consent form with the informed consent of the subjects. For the subjects who could not express their consent, they should provide the above introduction and explanation to their legal representatives, and the legal representatives should sign the informed consent forms; 9. Patients of childbearing age and their spouses are willing to take contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Patients with other serious diseases, including but not limited to: (1) Uncontrollable congestive heart failure (NYHA grade III or IV), unstable angina pectoris, poorly controlled arrhythmia, uncontrolled moderate hypertension (SBP > 160mmhg or DBP > 100mmhg); (2) Active infection; (3) Uncontrolled diabetes; (4) HIV infection; (5) Patients with interstitial pneumonia or low oxygen saturation; (6) Active autoimmune diseases requiring long-term steroid use; (7) Patients who have received allografts; (8) Mental illness affecting informed consent and / or protocol compliance. 2. Patients with ascites with symptoms and need clinical treatment; 3. Patients with serious diseases that other researchers consider unsuitable to participate in this study; 4. Patients who are known to be allergic to the drugs involved in the study; 5. Pregnant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactGong Wei
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed