TerminatedPhase 1/2

Evaluate the Effect of Tirazamine on Primary Liver Cancer.

Stopped: Company Operational Strategy Adjustment

China16 participantsStarted 2021-05-14

Plain-language summary

This Phase I/II trial aims to evaluate the pharmacokinetics, efficacy, and safety of tirapazamine administered via hepatic artery injection followed by TACE in patients with intermediate-stage HCC. The trial will compare the outcomes of TATE with standard TACE.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed * Age 18-80 years * Patient is eligible to do TAE or TACE treatment. * ECOG performance status score 0-1. * Child-Pugh score 5 - 7 . * No portal vein tumor thrombus, lymph node metastasis, peritoneal tumor seeding, or extrahepatic metastasis. Exclusion Criteria: * Prior liver transplantation * History of liver tumor embolization or radioembolization * Uncontrolled HBV or HCV infection * Significant cardiovascular, pulmonary, or renal disease * QTc prolongation or use of QTc-prolonging medications

What they're measuring

Peak Plasma Concentration (Cmax)

Timeframe: 24 hours post-first dose

Area under the plasma concentration versus time curve (AUC)

Timeframe: 24 hours post-first dose

Time to Maximum Concentration（Tmax）

Timeframe: 24 hours post-first dose

Terminal Elimination Half-life（T1/2）

Timeframe: 24 hours post-first dose

PFS

Timeframe: 36 months

Trial details

NCT IDNCT06848556

SponsorZhejiang Raygene Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-06

View on ClinicalTrials.gov More Hepato Cellular Carcinoma (HCC) trials