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

NCT05864105 | Active Not Recruiting Phase 2

• 1 other identifier: PM8002 -B006C-HCC-R
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 9

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.

Conditions

Hepatocellular Carcinoma

Keywords

PD-L1/VEGF; FOLFOX-4

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PM8002+FOLFOX-4

EXPERIMENTAL

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; Drug: FOLFOX regimen

Interventions

PM8002 BIOLOGICAL

PM8002 20mg/kg Q2W

PM8002+FOLFOX-4

FOLFOX regimen DRUG

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

PM8002+FOLFOX-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (9)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Jinhua Municipal Centeral Hospital Medical Group

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jieer Ying

  Cancer Hospital of The University of Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: April 22, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (9)