This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.
All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.
Voluntarily sign a written informed consent form.
Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Expected survival ≥ 3 months.
Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically/cytologically.
Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.
Poor compliance, unable to cooperate and describe treatment responses.
History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.
Single group
Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
DrugAll enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen)
Overall response rate (ORR)
Defined as proportion of patients who have a best response of CR or PR
Progress Free Survival （PFS）
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Adverse Events（AEs）
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
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