Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma

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 ≥ 10mm (CT scan slice thickness no greater than 5 mm)]
• Life expectancy ≥ 3 months
• The function of vital organs meets the following requirements: absolute neutrophilcount (ANC) ≥ 3.5 × 10^9/L; platelets ≥ 125 × 10^9/L; hemoglobin ≥ 8 g/dL; Serumalbumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence ofliver 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 previousanti-tumor treatment, and has recovered from adverse reactions to prior anti-tumortherapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(exceptalopecia)
• Female patients of childbearing potential (including early menopause, menopause < 2years, and non-surgical sterilization), male patients and their partners must agree touse effective contraceptive measures during the study
• Patients or their legal representatives can understand and offer informed consent,being willing to take part in the follow-up with good compliance

Exclusion Criteria:

• Pregnant or lactating women, men or women who are reluctant to take effectivecontraceptive measures
• Previous treatment with oncolytic viruses (such as T-VEC)
• Abnormal coagulation function, or having a bleeding tendency, or receivingthrombolytic or anticoagulant therapy
• Patients with poor glycemic control
• Known central nervous system tumors, including metastatic brain tumors
• Accompanied by any unstable systemic diseases, including but not limited to severeinfection, resistant hypertension, unstable angina, stroke or myocardial infarctionwithin 6 months, congestive heart failure, and serious cardiac arrhythmia requiringmedication, renal or metabolic disease requiring medication
• Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium,fluorouracil
• History of immunodeficiency or autoimmune disease, or receiving long-term systemicsteroid therapy within 7 days before enrollment, or any form of immunosuppressivetherapy
• Other conditions that are not suitable for participating in this trial