Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.
Biliary drainage and stent placement remains to be the main palliative treatment choice for advanced perihiliar cholangiocarcinoma (pCCA), and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced pCCA due to its high tumor control, survival benefit, and low toxicity. Thus, the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion chemotherapy with oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.
• 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.