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

A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

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:

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

Exclusion Criteria:

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