drugset / Trial / NCT05472896
TACE With Dicycloplatin(TP21) in Unresectable HCC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dicycloplatin | Unknown | 550 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 40 mg | — |