drugset / Trial / NCT05472896

TACE With Dicycloplatin(TP21) in Unresectable HCC

NCT05472896

Phase 3 Unknown 332 enrolled Gao-jun Teng
RandomizedParallel-groupSingle-blindTreatment

Summary

To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma: 1. Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). 2. Secondary efficacy endpoints: PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), time to progression (TTP), 1-year progression-free survival, 1-year survival and 2-year survival assessed by the investigator.

Timeline

Start
2022-06-09
Primary completion
2024-06-30
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dicycloplatin Unknown 550 mg/m2
Comparator Epirubicin Small molecule 40 mg