Biliary Drainage Plus HAIC in Locally Advanced pCCA
Perihilar Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Perihilar Cholangiocarcinoma focused on measuring Perihilar Cholangiocarcinoma, Hepatic arterial infusion chemotherapy, Biliary Drainage, Best Supportive Care
Eligibility Criteria
Inclusion Criteria:
- Locally advanced perihilar cholangiocarcinoma proved by histology or cytology.
- Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
- Age from 18 years old to 75 years old.
- The performance of Eastern Cooperative Oncology Group (ECOG) <2
- Child-Pugh A or Child-Pugh B (≤ grade 7).
- Expectant survival time ≥ 3 months.
Baseline blood count test and blood biochemical must meet following criteria:
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count ≥ 1.5×10^9/L;
- Blood platelet count ≥ 100×10^9/L;
- Serum creatinine ≤ 1.5 times of ULN;
- Albumin ≥ 30 g/L
- Patients sign informed consent.
Exclusion Criteria:
- Allergic to contrast agent.
- Pregnant or lactational.
- Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
- Previous systematic chemotherapy or radiotherapy.
- Patients with complications such as bile leakage and bleeding after PTCD
- N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites.
- History of organ transplantation.
- Coinstantaneous infection and need anti-infection therapy.
- Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
- Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
- Without legal capacity.
- Uncorrectable coagulation disorder.
- Obvious abnormal in ECG or obvious clinical symptoms of heartdisease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
- Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.
Sites / Locations
- Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BD-HAIC (Biliary drainage & HAIC)
BD-BSC (Biliary Drainage & Best supportive care)
The patients enrolled in this arm would receive external percutaneous biliary drainage plus 3Cir-OFF hepatic arterial infusion chemotherapy (HAIC)with oxaliplatin and 5-fluorouracil.
The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.