HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma

Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Intrahepatic cholangiocarcinoma (ICC) is associated with poor prognosis. This study aims to explore the efficacy and safety FOLFOX-HAIC in combination with targeted therapy and/or PD-1 inhibitors for patients with initially unresectable ICC, as well as its role in conversion therapy. Data were retrospectively reviewed for patients with locally advanced unresectable ICC treated with FOLFOX-HAIC combined with targeted therapy and/or PD-1 inhibitors. The treatment efficacy and safety were evaluated.

Inclusion Criteria:

1. Patients were initially diagnosed without any previous oncological treatment.
2. The tumor was assessed as unresectable by two hepatobiliary surgeons (BL and YY, with more than 15 years of experience). Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
3. At least one assessable intrahepatic lesion.
4. classified as Child-Pugh Grade A.
5. ECOG PS score 0-1.
6. baseline blood tests meet the following criteria: leukocytes ≥3.0×10^9/L; neutrophils ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥ 80g/L; serum ALT or AST ≤ 3 times of upper limit of normal (ULN); serum creatinine ≤1.5 x ULN; INR ≤ 1.5, or prothrombin time ≤ ULN + 4 seconds; albumin ≥ 30 g/L; total bilirubin ≤ 3 x ULN.

Exclusion Criteria:

1. severe underlying cardiac, pulmonary, or renal diseases.
2. a second primary malignancy.
3. prior history of organ transplantation.