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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05864105

Enrollment

Registered

2023-05-18

Start date

2022-04-22

Completion date

2026-06-30

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

PD-L1/VEGF, FOLFOX-4

Brief summary

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

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

Interventions

BIOLOGICALPM8002

PM8002 20mg/kg Q2W

DRUGFOLFOX regimen

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 \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026