Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Oxaliplatin

Fluorouracil

Iodine

Cadexomer iodine

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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.

Intra-arterial chemotherapy consisted of Oxaliplatin (40mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for22 hours) on days 1-3 every 4 weeks.

oxaliplatin and 5-fluorouracil

External biliary drainage, or biliary stent placement; Biliary stent placement plus Iodine-125 seed strands is allowed

Biliary Drainage

Nutrition support, symptomatic treatment, and other supportive treatments

Best Supportive Care

External biliary drainage

Xiaodong Wang

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.

When a patient is not eligible for surgery, chemotherapy with gemcitabine and cisplatin can be considered for advanced biliary tract cancer. However, in the Advanced Biliary Tract Cancer, or ABC-02 trial in patients with pCCA, the efficacy of this regimen was not significantly higher than that of gemcitabine alone. Therefore, an optimal chemotherapeutic regimen has not been established for this subtype of cholangiocarcinoma. Currently, biliary drainage and stent placement remains to be the main palliative treatment choice, and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that HAI with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity. So the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion of oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.

Biliary Drainage Plus HAIC in Locally Advanced pCCA

Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.

Toxicities were graded according to the Common Terminology Criteria for Adverse Events, version 4.0

Overall survival is measured from the date of first biliary drainage to death

The time between remission of total bilirubin to less than 2 times of the upper limit of the normal value and time of rising again of bilirubin above more than 2 times of upper limit of the normal level.

Spots Global Cancer Trial Database for external biliary drainage