A Clinical Trial for the Safety and Efficacy of CD-801 in Patients With Advanced Hepatocellular Carcinoma

Prior treatment

• Subjects with extrahepatic metastasis who had potential benefit from first-line systemic therapies.
• Subjects who had prior anticancer treatment with any locoregional therapies, antiangiogenic targeted therapies, immune checkpoint inhibitors or chemotherapy within 4 weeks (within 2 weeks in case of sorafenib), radiotherapy within 3 weeks, or active traditional Chinese medicine within 2 weeks before the first dose of study treatment, except for the treatments after which the disease still progressed according to mRECIST.
• All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).
• Subjects with complication histories of liver cirrhosis or HCC such as gastrointestinal hemorrhage, overt hepatic encephalopathy, or uncontrollable ascites within 2 weeks prior to the first dose of study treatment.
• Participation in other investigational drug trials within 4 weeks prior to initiation of this study treatment.

Other illness

• Subjects with a history of liver transplantation.
• Subjects with poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.
• Uncontrolled active infection (eg, lung infections, or abdominal infections).
• Subjects with moderate to severe hepatic artery- portal vein fistula or hepatic artery - vein fistula which could not be avoided even through the artery super selection by DSA.
• History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.
• HBV DNA greater than 500 copies/mL, or HCV RNA greater than 15 U/mL.
• Subject is positive for Human Immunodeficiency Virus (HIV).
• Any subject who is allergic to MRI contrast agents.
• Any medical or other condition which, in the opinion of the investigator, would preclude participation in this clinical trial.

Lab values

• ALB \< 28 g/L, or Bilirubin \>5.0 mg/dL, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \>5×ULN.
• Inadequate renal function defined as creatinine \>1.5 times the upper limit of normal (ULN) or calculated creatinine clearance \< 40 mL/min.
• Absolute neutrophil count (ANC) \< 1.0×109/L, or Platelets \< 30×109/L, or Hemoglobin \< 8.5 g/dL.
• International Normalized Ratio (INR) \> 2.3.

Other

• Pregnant/lactating women, or women who have the possibility of pregnancy.

• Males or females, aged 18 years or older.
• Subjects must have confirmed diagnosis of HCC according to the American Association for the Study of Liver Diseases criteria.
• Unresectable HCC.
• Subjects are unsuitable for local or systemic anti-tumor therapy or had tumor progression after receiving at least one kind of conventional treatment.
• According to mRECIST, subjects should be with at least 1 measurable target lesion.
• Life expectancy of 12 weeks or more.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
• Male with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.
• Subjects who have voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.