Table 1

Inclusion and exclusion criteria

Inclusion criteriaExclusion criteria

  • Age≥18 years old

  • Previously treated with HAIC or regorafenib

  • Pathologically or radiologically confirmed advanced HCC according to EASL and AASLD guidelines

  • Participated, participating or is going to participate in other therapeutic trials within 28 days before the treatment

  • Previously received first-line systemic therapy for advanced HCC

  • Absence of hepatic lesions

  • ECOG-PS score: 0–1

  • Have received or plan to undergo liver transplantation

  • At least one measurable lesion by RECIST version 1.1

  • Permanently stopped using sorafenib because of toxicity

  • Child-Pugh A or Child-Pugh B without cirrhosis

  • Clinically significant cardiovascular diseases

  • Adequate organ and haematologic function*

  • Active bleeding or there is a risk of bleeding

  • Sign the written informed consent and be able to comply with the treatment and follow-up procedures stipulated in the research programme

  • Recent, persistent or active infection

  • Serious unhealed injury, abdominal wall fistula, gastrointestinal fistula, gastrointestinal perforation, abdominal abscess, unhealed gastrointestinal ulcer or gastrointestinal obstruction within 6 months before the start of treatment

  • Allergic to any research drugs or related excipients

  • Other malignant tumours

  • Women during pregnancy or breastfeeding

  • Other diseases or states that could affect the results of the study or increase the occurrence of treatment-related adverse reactions based on the investigator’s consideration

  • *Adequate organ and haematologic function: white blood cell≥3.0×109/L, neutrophils≥1.5×109/L, platelets>75×109/L, haemoglobin>85 g/L; total serum bilirubin≤30 mmol/L, serum albumin≥2.8 g/dL, aspartate transferase≤1.5×ULN (upper limit of normal), alanine transferase≤1.5×ULN, international normalised ratio≤1.5 or activated partial thromboplastin time≤1.5×ULN, serum creatinine≤1.5×ULN and left ventricular ejection fraction≥45%.

  • AASLD, American Association for the Study of Liver Diseases; EASL, European Association for the Study of the Liver; ECOG-PS, Eastern Cooperative Oncology Group-performance status; HAIC, hepatic arterial infusion chemotherapy; HCC, hepatocellular carcinoma; RECIST, Response Evaluation Criteria in Solid Tumors.