Biliary tract cancer
Conditions
Interventions
Experimental group:Hepatic arterial infusion chemotherapy combined with systemic therapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced biliary malignancies confirmed by histopathology or cytopathology (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma and gallbladder cancer) 2. Without distant metastasis or with relatively limited distant metastasis 3. Previously untreated 4. Age 18-80 years 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score = 90 g/L; b. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; c. Platelet count >= 75 × 10^9/L; Blood biochemical examination (within 14 days before screening and no use of albumin): a. Albumin >= 30 g/L; b. Total bilirubin <= 5 × upper limit of normal (ULN); c. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 5 × ULN; d. Creatinine <= 1.5 × ULN; Coagulation function: a. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; b. Activated partial thromboplastin time (APTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Dual primary or multiple primary cancers 2. Cancer in the lower segment of the bile duct 3. Allergy to contrast agent or oxaliplatin 4. Pregnant or lactating women 5. Multiple extrarenal metastases or combined with malignant pleural or peritoneal effusion 6. History of organ transplantation 7. Patients with infection requiring anti-infection treatment 8. Severe and irreparable coagulation dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Clinical complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Adverse events; | — |
Countries
China
Contacts
Public ContactXiaodong Wang
Beijing Cancer Hospital
Outcome results
None listed