Clinical Research Directory
Browse clinical research sites, groups, and studies.
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
Sponsor: Biotheus Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2022-04-22
Completion Date
2026-06
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
PM8002
PM8002 20mg/kg Q2W
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 \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]
Locations (9)
Anhui Provincial Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Hospital of Jilin University
Changchun, Jilin, China
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang, China