Initially Unresectable Hepatocellular CarcinomaNCT07480382
Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC
A study testing Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization(C-TACE) and Tislelizumab combined with Lenvatinib in people with Initially Unresectable Hepatocellular Carcinoma, run by Hong Wu at 1 site in China.
Trial summary
This study evaluates a novel "Dual-Conversion" strategy (mechanical volume conversion via LVD plus biological conversion via cTACE, Tislelizumab, and Lenvatinib) for patients with initially unresectable right-sided hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Initially Unresectable Hepatocellular Carcinoma
- What is being tested?
- Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization(C-TACE) and Tislelizumab combined with Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Confirmed HCC (histologically or by AASLD clinical criteria).
- Initially unresectable HCC limited to the right liver (due to insufficient FLR or tumor characteristics).
- Child-Pugh score ≤ 7 (Class A or early B).
- ECOG Performance Status of 0 or 1.
- Adequate organ function (marrow, hepatic, and renal).
Who cannot join
- Extrahepatic metastasis.
- Portal vein tumor thrombus involving the main trunk (Vp4).
- Previous systemic therapy for HCC.
- Active autoimmune disease or history of organ transplantation.
- Contraindications to LVD, TACE, or the study drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 614000
Qingyun Xie, M.D., Ph.D., 18608070908, xieqingyun@stu.scu.edu.cn
Chang Liu, M.D., Ph.D., +86-18581575861, drliuchang@wchscu.cn
About this study
Official title: A Prospective, Single-Center, Single-Arm Trial to Validate the Safety and Efficacy of "Dual-Conversion" Therapy With Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization (cTACE), Tislelizumab, and Lenvatinib for Initially Unresectable Hepatocellular Carcinoma in the Right Liver.
This study evaluates a novel "Dual-Conversion" strategy (mechanical volume conversion via LVD plus biological conversion via cTACE, Tislelizumab, and Lenvatinib) for patients with initially unresectable right-sided hepatocellular carcinoma (HCC). The primary goal is to assess the rate of successful conversion to R0 resection and the safety profile of this multi-modal approach.
Read the detailed description
For patients with large right-sided HCC, resection is often precluded by insufficient future liver remnant (FLR) or high biological aggressiveness. This trial utilizes:
- Mechanical Conversion: LVD (simultaneous portal and hepatic vein embolization) to trigger rapid FLR hypertrophy.
- Biological Conversion: cTACE combined with systemic therapy (Tislelizumab + Lenvatinib) to control tumor growth and reduce tumor stage.
Patients will undergo "Dual-Conversion" therapy and be assessed for surgical resectability every 3-6 weeks. Success is defined as achieving R0 resection with a safe FLR-to-body weight ratio.
- Being tested
- Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization(C-TACE), Tislelizumab combined with Lenvatinib
- Keywords
- Liver Venous Deprivation, Dual-Conversion, Tislelizumab, Lenvatinib, Transarterial Chemoembolization, Liver Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Venous Deprivation (LVD)Procedure or surgery
Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
Conventional Transarterial Chemoembolization(C-TACE)Procedure or surgery
Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)
Tislelizumab combined with LenvatinibDrug
Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W) + 8 mg (for weight <60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Dual-Conversion Therapy Group | Experimental | Patients receive a combination of LVD, cTACE, Tislelizumab, and Lenvatinib.
• Interventions:
* Procedure: Liver Venous Deprivation (LVD) Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
* Procedure: cTACE Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin).
* Drug: Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W).
* Drug: Lenvatinib 8 mg (for weight <60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD). Receives: Procedure: Liver Venous Deprivation (LVD); Procedure: Conventional Transarterial Chemoembolization(C-TACE); Drug: Tislelizumab combined with Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion-to-Surgery Rate
The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (4)
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) based on mRECIST and RECIST 1.1 criteria.
Measured: Every 4-8 weeks (up to 3 years)
Kinetic Growth Rate (KGR) of FLR
Volume increase of the Future Liver Remnant (FLR) per week (mL/week) measured by CT-based 3D reconstruction post-LVD.
Measured: 3-4 weeks post-LVD.
Progression-Free Survival (PFS)
Time from enrollment to disease progression or death from any cause.
Measured: Every 4-8 weeks (up to 3 years).
Incidence of Treatment-Related Adverse Events (TRAEs)
Frequency and severity of adverse events graded by CTCAE v5.0, including TACE/LVD-related complications and immune/target-related toxicities.
Measured: From the first dose until 30 days after the last treatment (up to 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Initially Unresectable Hepatocellular CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm trial designed to evaluate a "dual-conversion" strategy. All enrolled participants will receive a standardized multimodal intervention consisting of mechanical volume conversion (Liver Venous Deprivation, LVD) and biological conversion (Conventional Transarterial Chemoembolization \[cTACE\] combined with Tislelizumab and Lenvatinib). The study employs a single-group model to assess the safety and the rate of conversion to successful surgical resection in patients with initially unresectable right-sided hepatocellular carcinoma.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Wu, West China Hospital
- Investigators
- Hong Wu, M.D., Ph.D., Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480382
- Sponsor's protocol ID
- iDUCONVER-001
- Other IDs
- Approval No. 2025-1082
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm Trial to Validate the Safety and Efficacy of "Dual-Conversion" Therapy With Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization (cTACE), Tislelizumab, and Lenvatinib for Initially Unresectable Hepatocellular Carcinoma in the Right Liver.
- ClinicalTrials.gov ID
- NCT07480382
- Acronym / sponsor ID
- iDUCONVER-001
- Keywords
- Liver Venous Deprivation, Dual-Conversion, Tislelizumab, Lenvatinib, Transarterial Chemoembolization, Liver Resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hong WuUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Mar 2026 (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 study evaluates a novel "Dual-Conversion" strategy (mechanical volume conversion via LVD plus biological conversion via cTACE, Tislelizumab, and Lenvatinib) for patients with initially unresectable right-sided hepatocellular carcinoma (HCC). The primary goal is to assess the rate of successful conversion to R0 resection and the safety profile of this multi-modal approach.
Detailed description
For patients with large right-sided HCC, resection is often precluded by insufficient future liver remnant (FLR) or high biological aggressiveness. This trial utilizes:
- Mechanical Conversion: LVD (simultaneous portal and hepatic vein embolization) to trigger rapid FLR hypertrophy.
- Biological Conversion: cTACE combined with systemic therapy (Tislelizumab + Lenvatinib) to control tumor growth and reduce tumor stage.
Patients will undergo "Dual-Conversion" therapy and be assessed for surgical resectability every 3-6 weeks. Success is defined as achieving R0 resection with a safe FLR-to-body weight ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm trial designed to evaluate a "dual-conversion" strategy. All enrolled participants will receive a standardized multimodal intervention consisting of mechanical volume conversion (Liver Venous Deprivation, LVD) and biological conversion (Conventional Transarterial Chemoembolization [cTACE] combined with Tislelizumab and Lenvatinib). The study employs a single-group model to assess the safety and the rate of conversion to successful surgical resection in patients with initially unresectable right-sided hepatocellular carcinoma.
| Arm | Type | Receives |
|---|---|---|
| Dual-Conversion Therapy Group | Experimental | Procedure: Liver Venous Deprivation (LVD), Procedure: Conventional Transarterial Chemoembolization(C-TACE), Drug: Tislelizumab combined with LenvatinibPatients receive a combination of LVD, cTACE, Tislelizumab, and Lenvatinib. • Interventions: * Procedure: Liver Venous Deprivation (LVD) Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy. * Procedure: cTACE Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin). * Drug: Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W). * Drug: Lenvatinib 8 mg (for weight <60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Confirmed HCC (histologically or by AASLD clinical criteria).
- Initially unresectable HCC limited to the right liver (due to insufficient FLR or tumor characteristics).
- Child-Pugh score ≤ 7 (Class A or early B).
- ECOG Performance Status of 0 or 1.
Key exclusion criteria (5 listed)
- Extrahepatic metastasis.
- Portal vein tumor thrombus involving the main trunk (Vp4).
- Previous systemic therapy for HCC.
- Active autoimmune disease or history of organ transplantation.
- Contraindications to LVD, TACE, or the study drugs
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 |
|---|---|---|
| Liver Venous Deprivation (LVD)Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy. | Procedure or surgery | Dual-Conversion Therapy Group |
| Conventional Transarterial Chemoembolization(C-TACE)Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin) | Procedure or surgery | Dual-Conversion Therapy Group |
| Tislelizumab combined with LenvatinibTislelizumab 200 mg administered intravenously every 3 weeks (Q3W) + 8 mg (for weight <60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD) | Drug | Dual-Conversion Therapy Group |
Primary outcome
Conversion-to-Surgery Rate
Time frame: From enrollment to the end of treatment at 12 weeks
The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Every 4-8 weeks (up to 3 years)
Kinetic Growth Rate (KGR) of FLR
Time frame: 3-4 weeks post-LVD.
Progression-Free Survival (PFS)
Time frame: Every 4-8 weeks (up to 3 years).
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From the first dose until 30 days after the last treatment (up to 2 years).
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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
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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.
Hong Wu, M.D., Ph.D. study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization(C-TACE) and Tislelizumab combined with Lenvatinib in people with Initially Unresectable Hepatocellular Carcinoma, run by Hong Wu at 1 site 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 5 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Qingyun Xie, M.D., Ph.D. (+8618608070908, xieqingyun@stu.scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion-to-Surgery Rate (time frame: From enrollment to the end of treatment at 12 weeks). 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 18 Mar 2026.