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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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

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