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ACTIVE NOT RECRUITING
NCT05864105
PHASE2

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

Sponsor: Biotheus Inc.

View on ClinicalTrials.gov

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

Interventions

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

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