biliary tract cancer
Conditions
Interventions
1:targeted/immune therapy+chemotherapy
2:??
Sponsors
Shanghai Cancer Center, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. ECOG 0~1; 3. Histologically or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma; 4. Preoperative stage III /IVa/TxN1M0; 5. The main organs function well, and the examination indexes meet the following requirements: Blood routine examination: Hemoglobin >=90 g/L (without blood transfusion within 14 days); Neutrophil count >=1.5x10^9/L; Platelet count >=80x10^9/L; Biochemical examination: Total bilirubin =50 ml/min (Cockcroft-Gault formula); 6. Voluntary signing of informed consent; 7. Good compliance, family members are willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Having other incurable malignant tumors at the same time; 2. For pregnant or lactating women, withdrawal from the clinical trial is required if the subject becomes pregnant during the study period; 3. Previously anti-tumor therapy for the disease in this study; 4. Participated in other drug clinical trials within one month; 5. Patients with known history of other serious systemic diseases before screening; 6. Long-term unhealed wound or incomplete fracture; 7. A history of organ transplantation; 8. Abnormal coagulation function (PT >=16 s), with bleeding tendency;Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs;Low-dose warfarin (1 mg oral, qD) or low-dose aspirin (not more than 100 mg daily) is permitted for prophylactic purposes as long as the international standard ratio of prothrombin time (INR) <=1.5; 9. Screening for previous arterial/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism in the previous year; 10. Has a history of abuse of psychotropic substances and is unable to quit or has a mental disorder; 11. A history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 12. Concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progress free survival;safety;overall response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactLongrong Wang
Shanghai Cancer Center, Fudan University
Outcome results
None listed