Hepatocellular Carcinoma Non-resectablePhase 3NCT06492395
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
A Phase 3 study testing Len+DEB-TACE+HAIC and Len+DEB-TACE in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Len+DEB-TACE+HAIC and Len+DEB-TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a confirmed diagnosis of HCC
- the largest intrahepatic lesion >7 cm
- presence of PVTT on imaging
- tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- Eastern Cooperative Oncology Group performance status ≤1
- Child-Pugh class A/B
- adequate hematologic and organ function, with leukocyte count>3.0×10^9/L, neutrophil count>1.5×10^9/L, platelet count≥75×10^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
- life expectancy of at least 3 months
Who cannot join
- Diffuse HCC
- accompanied with vena cava tumor thrombus
- central nervous system involvement
- previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
- history of other malignancies
Show all 10Show fewer
- uncontrollable infection
- history of HIV
- history of organ or cells transplantation
- prothrombin time prolongation >4 s
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@163.com
About this study
Official title: A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis
This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (> 7cm) with portal vein tumor thrombosis (PVTT).
Read the detailed description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (>7cm) with PVTT.
178 patients with large HCC (> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.
The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Len+DEB-TACE+HAIC, Len+DEB-TACE
- Keywords
- hepatocellular carcinoma, lenvatinib, transarterial chemoembolization, drug-eluting bead, hepatic arterial infusion chemotherapy, portal vein tumor thrombosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Len+DEB-TACE+HAICCombination product
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.
During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Len+DEB-TACECombination product
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
| Study group | Role | What they receive |
|---|---|---|
| Len+DEB-TACE+HAIC | Experimental | Patients will receive the combination treatment of Len+DEB-TACE+HAIC. Receives: Combination Product: Len+DEB-TACE+HAIC |
| Len+DEB-TACE | Active comparator | Patients will receive the combination treatment of Len+DEB-TACE. Receives: Combination Product: Len+DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
Measured: 2 years
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: 2 years
Disease control rate (DCR)
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.
Measured: 2 years
Overall survival (OS)
The time from date of randomization to death due to any cause.
Measured: 3 years
Adverse Events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492395
- Sponsor's protocol ID
- MIIR-18
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT06492395
- Acronym / sponsor ID
- MIIR-18
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- hepatocellular carcinoma, lenvatinib, transarterial chemoembolization, drug-eluting bead, hepatic arterial infusion chemotherapy, portal vein tumor thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Jul 2024 (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 is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (> 7cm) with portal vein tumor thrombosis (PVTT).
Detailed description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (>7cm) with PVTT.
178 patients with large HCC (> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.
The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Len+DEB-TACE+HAIC | Experimental | Combination Product: Len+DEB-TACE+HAICPatients will receive the combination treatment of Len+DEB-TACE+HAIC. |
| Len+DEB-TACE | Active comparator | Combination Product: Len+DEB-TACEPatients will receive the combination treatment of Len+DEB-TACE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- a confirmed diagnosis of HCC
- the largest intrahepatic lesion >7 cm
- presence of PVTT on imaging
- tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- Eastern Cooperative Oncology Group performance status ≤1
Key exclusion criteria (10 listed)
- Diffuse HCC
- accompanied with vena cava tumor thrombus
- central nervous system involvement
- previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
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 |
|---|---|---|
| Len+DEB-TACE+HAICFor DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC. | Combination product | Len+DEB-TACE+HAIC |
| Len+DEB-TACEFor DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC. | Combination product | Len+DEB-TACE |
Primary outcome
Time to progression (TTP)
Time frame: 2 years
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
4 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Overall survival (OS)
Time frame: 3 years
Adverse Events (AEs)
Time frame: 3 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 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Len+DEB-TACE+HAIC and Len+DEB-TACE in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University 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 8 inclusion and 10 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 29 Jan 2025. 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.
What does this phase mean?
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 Mingyue Cai, Dr. (+86-20-34156205, cai020@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (TTP) (time frame: 2 years). 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 29 Jan 2025.