Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma
Trial Parameters
Brief Summary
Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years, male or female * Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery * At least one measurable lesion according RECIST v1.1 criteria \[spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\] * Life expectancy ≥ 3 months * The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10\^9/L; platelets ≥ 125 × 10\^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF \> 50% * The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia) * Female patients of childbearing potent