Biliary tract cancer
Conditions
Interventions
Experimental Group:Hepatic arterial infusion chemotherapy(HAIC): irinotecan liposome injection 50mg/m^2 -- LV 400 mg/m^2 -- 5-FU 2400 mg/m^2, 48-72h.HAIC treatment is
Bevacizumab 200mg ivgtt ± sintil
Sponsors
Affiliation Hospital of JiangNan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender unlimited; 2. Unresectable advanced biliary tract cancer (intrahepatic, extrahepatic cholangiocarcinoma, gallbladder cancer, T1 and beyond) confirmed by histopathology or cytology; 3.ECOG score 0-1; 4. No distant metastasis; 5. At least one measurable lesion suitable for repeated and accurate measurement according to RECIST v1.1; 6. The expected survival time is more than 3 months; 7. Left ventricular ejection fraction (LVEF)>=50% and normal myocardial enzymes; 8. Adequate organ function: specific bone marrow function: neutrophil (ANC) >=1.5×10^9/L, platelet (PLT) >=100×10^9/L, hemoglobin (Hb) >=90g/L, white blood cell (WBC) >=3.0×10^9/L; Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60 ml/min (calculated by Cockroft-Gault); 9. Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR)<=1.5 × ULN; 10. Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; No active or suspected infection was allowed; 11. Adverse events after previous treatment had to return to grade 1 or baseline according to CTCAE5.0 (except for toxicities such as alopecia and grade 2 or lower peripheral neuropathy, which were judged by the investigator to be no safety risk). 12. Women who are not pregnant or lactating; Women/men of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment; 13. No contraindications to study drug use; 14.Patients had good compliance, understood the study process, and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) within the past 3 years; 2. History of gastrointestinal bleeding or obvious tendency of gastrointestinal bleeding within 6 months before the study, such as esophagogastric varices with risk of bleeding, active local ulcers, and persistent positive fecal occult blood; 3. any known brain or leptomeningeal metastases; 4. Patients with concomitant use of a potent CYP3A4 inducer or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks before the first dose; (5) patients undergoing major organ surgery (excluding needle biopsy, central venous catheterization, port catheterization, stent placement for biliary obstruction, percutaneous hepatobiliary drainage, or cholecystostomy) or elective surgery within 4 weeks before the first dose of study drug; 6. Subjects with active infection or unexplained fever >38.5 ° C during screening or before the first dose of medication (tumor-related fever was considered by the investigator to be eligible); 7. Subjects with congenital or acquired immune deficiency, such as HIV infection or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA>=1000 IU/ml; Hepatitis C reference: HCV RNA>=1000 IU/ml); Chronic hepatitis B virus carriers, HBV DNA grade 1 diarrhea, stool frequency increased more than 4 times per day compared with baseline; The discharge from the stoma increased moderately or severely. Limited activities of daily living with the help of tools or even limited activities of daily living by themselves; Life-threatening; The need for urgent treatment; 12. Have participated in other clinical investigators within 4 weeks before enrollment; 13. Patients deemed by the investigator to be ineligible for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diseae Control Rate;Progression Free Survival;Overall survivial; Incidence of Adverse Events [Safety]; | — |
Countries
China
Contacts
Public ContactWu Qinghua
Affiliation Hospital of JiangNan University
Outcome results
None listed