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.
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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 \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]
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
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.
Time frame: Up to approximately 2 years
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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