Biliary Drainage Plus HAIC in Locally Advanced pCCA
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
When a patient is not eligible for surgery, chemotherapy with gemcitabine and cisplatin can
be considered in advanced biliary tract cancers. However, in the Advanced Biliary Cancer, or
ABC-2, 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.