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RecruitingNCT06844357Updated Apr 6, 2025

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

A Phase 2/3 interventional study of tirapazamine and Transarterial Embolization (TAE) in HCC, sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HCC
03

In context

Lead sponsor

Zhejiang Raygene Pharmaceuticals Co., Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    TATE

    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)

  • Experimental
    TACE

    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

  • Drugtirapazamine

    Intra-arterial injection into the tumor feeding artery

  • ProcedureTransarterial Embolization (TAE)

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

  • ProcedureTACE

    TACE with epirubicin

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

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

    Time frame: 36 months

Secondary outcomes

  1. Complete Response (CR) rate

    Complete response rate (CR) assessed by IRC using mRECIST criteria

    Time frame: 36 months

  2. objective response rate (ORR)

    Time frame: 36 months

  3. duration of complete response (DOCR)

    Time frame: 36 months

  4. overall survival (OS)

    Time frame: 36 months

07

Study locations

2 of 2 sites recruiting
  • Zhongda Hospital, Affiliated to Southeast University
    Nanjing, Jiangsu 210009, China
    Recruiting
  • Lishui Central Hospital
    Lishui, Zhejiang 323000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Privacy Protection for Participants

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06844357
Lead sponsor
Zhejiang Raygene Pharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Feb 25, 2025
Start date
Mar 27, 2025
Primary completion
Apr 1, 2029 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Apr 6, 2025

Study contacts

Bill Shen, Ph.D.
Contact
bill.shen@raygene.cn
057185131875
Gaojun Teng, M.D
principal investigator · Zhongda Hospital
Jiansong Ji, M.D
principal investigator · The Central Hospital of Lishui City

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tirapazamine

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Zhejiang Raygene Pharmaceuticals Co., Ltd

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