PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma

This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.

PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.

Inclusion Criteria:

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
2. Male or female aged >= 18 years;
3. HCC diagnosed by pathology or clinical;
4. BCLC stage C or B (unresectable or/and not suitable for local therapy);
5. Child-Pugh score <= 7;
6. ECOG performance status of 0 or 1.

Exclusion Criteria:

1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
2. Symptomatic CNS metastases, not suitable for the study assessed by investigator;
3. Evidence of major coagulopathy or other obvious risk of bleeding;
4. Unable to accept enhanced imaging examination (CT or MRI) for any reason;
5. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
9. Patients with psychiatric disorders or poor compliance;
10. Women who are pregnant or breastfeeding;
11. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE;
12. Other conditions lead to inappropriate to participate in this study as judged by the investigator.