HCCPhase 2/3NCT06844357
A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
A Phase 2/3 study testing tirapazamine, Transarterial Embolization (TAE) and TACE in people with HCC, run by Zhejiang Raygene Pharmaceuticals Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- tirapazamine, Transarterial Embolization (TAE) and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 27 Mar 2025to 1 Apr 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323000
Jiansong Ji, M.D., 13857088508, jjstcty@sina.com
- Recruiting
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, 210009
Gaojun Teng, M.D., 13805171500, gjteng@vip.sina.com
About this study
Official title: A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)
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
- Being tested
- tirapazamine, Transarterial Embolization (TAE), TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirapazamineDrug
Intra-arterial injection into the tumor feeding artery
Transarterial Embolization (TAE)Procedure or surgery
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
TACEProcedure or surgery
TACE with epirubicin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.
Measured: 36 months
Secondary outcomes (4)
Complete Response (CR) rate
Complete response rate (CR) assessed by IRC using mRECIST criteria
Measured: 36 months
objective response rate (ORR)
Measured: 36 months
duration of complete response (DOCR)
Measured: 36 months
overall survival (OS)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start27 Mar 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Raygene Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaojun Teng, M.D, Principal investigator, Zhongda HospitalJiansong Ji, M.D, Principal investigator, The Central Hospital of Lishui City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844357
- Sponsor's protocol ID
- RG001
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy Protection for Participants
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT06844357
- Acronym / sponsor ID
- RG001
- Conditions
- HCC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Raygene Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TATE | Experimental | Drug: tirapazamine, Procedure: Transarterial Embolization (TAE)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. |
| TACE | Experimental | Procedure: TACEPatients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tirapazamineIntra-arterial injection into the tumor feeding artery | Drug | TATE |
| Transarterial Embolization (TAE)Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia | Procedure or surgery | TATE |
| TACETACE with epirubicin | Procedure or surgery | TACE |
Primary outcome
Progression-free survival (PFS)
Time frame: 36 months
Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.
4 secondary outcomes
Complete Response (CR) rate
Time frame: 36 months
objective response rate (ORR)
Time frame: 36 months
duration of complete response (DOCR)
Time frame: 36 months
overall survival (OS)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No. Privacy Protection for Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaojun Teng, M.D principal investigator
Zhongda Hospital
Jiansong Ji, M.D principal investigator
The Central Hospital of Lishui City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tirapazamine, Transarterial Embolization (TAE) and TACE in people with HCC, run by Zhejiang Raygene Pharmaceuticals Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bill Shen, Ph.D. (057185131875, bill.shen@raygene.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.