A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects.

The second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.

Inclusion criteria

• Voluntary participation in clinical studies;
• Male or female, aged ≥ 18 years;
• Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
• Child-Pugh liver function score ≤7；
• No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
• At least 1 measurable lesion ；
• Adequate organ function；
• ECOG score of 0 to 1；
• Life expectancy ≥ 12 weeks;

Exclusion criteria

• Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
• History of serious allergic diseases；
• The toxicity of previous anti-tumor therapy has not been alleviated；
• History of severe cardiovascular diseases within 6 months;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol abuse, psychotropic substance abuse or drug abuse;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.