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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: PM8002
* Drug: FOLFOX regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; Male or female aged >= 18 years; HCC diagnosed by pathology or clinical; BCLC stage C or B (unresectable or/and not suitable for local therapy); Child-Pugh score <= 7; ECOG performance status of 0 or 1. Exclusion Criteria: Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; Symptomatic CNS metastases, not suitable for the study assessed by investigator; Evidence of major coagulopathy or other obvious risk of bleeding; Unable to accept enhanced imaging examination (CT or MRI) for any reason; History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; Human immunodeficiency virus infection or known acquired immunodeficiency syndrome; Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of alcohol abuse, psychotropic drug abuse or drug abuse; Patients with psychiatric disorders or poor compliance; Women who are pregnant or breastfeeding; 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; Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PM8002+FOLFOX-4<br>PM8002 20mg/kg Q2W day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion] | Biological: PM8002<br>* PM8002 20mg/kg Q2W<br>Drug: FOLFOX regimen<br>* day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-L1/VEGF, FOLFOX-4