A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.

NCT06844357 | Recruiting Phase 2 DMC

• 1 other identifier: RG001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.

  36 months

Secondary Outcomes (4)

• Complete Response (CR) rate

  36 months

• objective response rate (ORR)

  36 months

• duration of complete response (DOCR)

  36 months

• overall survival (OS)

  36 months

Study Arms (2)

TATE

EXPERIMENTAL

Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.

Drug: tirapazamine; Procedure: Transarterial Embolization (TAE)

TACE

EXPERIMENTAL

Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.

Procedure: TACE

Interventions

tirapazamine DRUG

Intra-arterial injection into the tumor feeding artery

TATE

Transarterial Embolization (TAE) PROCEDURE

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

TATE

TACE PROCEDURE

TACE with epirubicin

TACE

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.
• No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.
• Patients must be eligible for TAE or TACE treatment.
• ECOG ≤ 1.
• Child-Pugh score ≤ 7.
• Adequate bone marrow, liver, and kidney function is required.

You may not qualify if:

• History of liver transplantation.
• Previous radioemblization or radiotherapy for liver tumors.
• severe cardiovascular or renal diseases, active systemic infections.
• Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)

Sponsors & Collaborators

• Zhejiang Raygene Pharmaceuticals Co., Ltd: lead

Study Sites (2)

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Interventions

Tirapazamine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gaojun Teng, M.D

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

• Jiansong Ji, M.D

  The Central Hospital of Lishui City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bill Shen, Ph.D.

CONTACT

057185131875; bill.shen@raygene.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)