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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: PM8002; Drug: FOLFOX regimen

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincial Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First affiliated hospital, Sun Yat-sen University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Cancer Hospital of The University of Chinese Academy of Sciences
    • Jinhua, Zhejiang, China
      • Jinhua Municipal Centeral Hospital Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PM8002+FOLFOX-4; 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; PM8002 20mg/kg Q2W; Drug: FOLFOX 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]

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biotheus Inc.
• Investigators: Principal Investigator: Jieer Ying, Cancer Hospital of The University of Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: FOLFOX-4; PD-L1/VEGF
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Folfox protocol
• Other Study ID Numbers: PM8002 -B006C-HCC-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No