Hepatocellular Carcinoma Non-resectablePhase 2NCT06904196
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
A Phase 2 study testing Lenvatinib plus SIRT and Lenvatinib 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 SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE). 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?
- Lenvatinib plus SIRT and Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Mar 2029
- Phase
- Phase 2
- 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
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Tumor extent <70% liver occupation
- Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- Adequate organ and hematologic function with platelet count ≥50×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
- Life expectancy of at least 3 months
Who cannot join
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
- History of esophageal or gastric variceal bleeding
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- History of hepatic encephalopathy
- History of other malignancies
- Human immunodeficiency virus infection
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: Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study
This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Read the detailed description
This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC.
78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN.
Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT.
The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Lenvatinib plus SIRT, Lenvatinib
- Keywords
- hepatocellular carcinoma, Lenvatinib, Yttrium-90
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib plus SIRTCombination product
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD will be started at 3-7 days after the first SIRT.
LenvatinibDrug
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD.
| Study group | Role | What they receive |
|---|---|---|
| Len+SIRT | Experimental | Lenvatinib plus SIRT Receives: Combination Product: Lenvatinib plus SIRT |
| LEN | Active comparator | Lenvatinib alone Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST
Measured: 3 years
Secondary outcomes (6)
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST.
Measured: 3 years
Progression free survival (PFS)
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 3 years
Time to response (TTR)
The time from treatment initiation to first tumour remission (mRECIST)
Measured: 3 years
Duration of response (DOR)
Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first)
Measured: 3 years.
Overall survival (OS)
The time from date of treatment initiation to death due to any cause
Measured: 4 years.
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE 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 posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingyue Cai, Dr., Study chair, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904196
- Sponsor's protocol ID
- MIIR-21
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06904196
- Acronym / sponsor ID
- MIIR-21
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- hepatocellular carcinoma, Lenvatinib, Yttrium-90
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 1 Apr 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 study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Detailed description
This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC.
78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN.
Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT.
The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Len+SIRT | Experimental | Combination Product: Lenvatinib plus SIRTLenvatinib plus SIRT |
| LEN | Active comparator | Drug: LenvatinibLenvatinib alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
Key exclusion criteria (9 listed)
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
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 |
|---|---|---|
| Lenvatinib plus SIRTLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD will be started at 3-7 days after the first SIRT. | Combination product | Len+SIRT |
| LenvatinibLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD. | Drug | LEN |
Primary outcome
Objective response rate (ORR)
Time frame: 3 years
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST
6 secondary outcomes
Disease control rate (DCR)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
Time to response (TTR)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years.
Overall survival (OS)
Time frame: 4 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 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Mingyue Cai, Dr. study chair
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib plus SIRT and Lenvatinib 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 10 inclusion and 9 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 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Objective response rate (ORR) (time frame: 3 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 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.