Evaluate the Effect of Tirazamine on Primary Liver Cancer.

NCT06848556 | Terminated Phase 1 DMC

• 1 other identifier: LT005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

TATE; TACE; pharmacokinetics; HEPATOCELLULAR CARCINOMA

Outcome Measures

Primary Outcomes (5)

• Peak Plasma Concentration (Cmax)

  Part I: One of the Pharmacokinetic Characteristics

  24 hours post-first dose

• Area under the plasma concentration versus time curve (AUC)

  Part I: One of the Pharmacokinetic Characteristics

  24 hours post-first dose

• Time to Maximum Concentration（Tmax）

  Part I: One of the Pharmacokinetic Characteristics

  24 hours post-first dose

• Terminal Elimination Half-life（T1/2）

  Part I: One of the Pharmacokinetic Characteristics

  24 hours post-first dose

• PFS

  Part two: Compare the difference in progression-free survival of patients after TATE/TACE treatment to evaluate whether TATE is superior to traditional TACE.

  36 months

Secondary Outcomes (3)

• OS

  36 months

• CR

  36 months

• ORR

  36 months

Study Arms (2)

TATE

EXPERIMENTAL

Part one is a multicenter, open-label, dose-escalation clinical trial. The starting dose of Tirapazamine was 5 mg/m² (for 3 patients), followed by 10 mg/m² (for 3 patients) and 20 mg/m² (for 6 patients). All patients received Tirapazamine injected into the hepatic artery that supplies the tumor, followed by an injection of iodized oil, a mixture of gelatin sponge and contrast agent to complete the embolization. Part Two is a Phase II open-label, randomized, controlled trial. Patients in the experimental group (Group A) will using a fixed dose of 35 mg of tirapazamine injected into the hepatic artery that supplies the tumor, followed by an injection of iodized oil, a mixture of gelatin sponge and contrast agent to complete the embolization.

Drug: tirapazamine; Procedure: Transarterial Embolization

TACE

EXPERIMENTAL

Part Two: Patients in the control group (Group B) received standard Transarterial Chemoembolization (TACE) with intra-arterial injection of a mixture of epirubicin and iodized oil at a personalized dose, followed by embolization completed by injecting a suspension of gelatin sponge and contrast agent.

Procedure: TACE

Interventions

tirapazamine DRUG

Intra-arterial injection into the tumor feeding artery

TATE

Transarterial Embolization PROCEDURE

Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia

Also known as: TAE

TATE

TACE PROCEDURE

Patients received standard Transarterial Chemoembolization (TACE) with intra-arterial injection of a mixture of epirubicin and iodized oil at a personalized dose, followed by embolization completed by injecting a suspension of gelatin sponge and contrast agent.

Also known as: Transarterial Chemoembolization

TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Raygene Pharmaceuticals Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tirapazamine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Caifang Ni, M.D

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: May 14, 2021
• Primary Completion: November 6, 2023
• Study Completion: November 20, 2023
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)