HAIC Combined With Tislelizumab and Apatinib for Unresectable Intrahepatic Cholangiocarcinoma
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular
carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma
accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most
patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical
resection. In locally advanced ICC patients without distant metastases, although the tumor
was initially assessed as unresectable, these patients may have the opportunity for surgical
resection after reducing the size tumor lesion and increasing the remnant liver volume
through conversion therapy. The current standard first-line treatment for unresectable ICC is
gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and
an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN
guidelines recommend that patients could participate in clinical study. Hepatic arterial
infusion chemotherapy can increase the local blood drug concentration and improve the tumor
regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the
incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be
a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy
combined with targeted therapy is expected to improve the prognosis of patients with
intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic
arterial infusion chemotherapy combined with tislelizumab and apatinib in the treatment of
unresectable ICC.