Hepatocellular CarcinomaPhase 2NCT05992584
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
A Phase 2 study testing Lenvatinib, sintilimab plus SIRT in people with Hepatocellular Carcinoma, 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, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib, sintilimab plus SIRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 9 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 session of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
Who cannot join
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
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- History of organ and cell transplantation
- Prior esophageal and/or gastric varices bleeding
- History of hepatic encephalopathy
- Peripheral blood white blood cell count<3×10^9/L, platelet count<50×10^9/L
- Prolongation of prothrombin time ≥ 4 seconds
- Severe organ dysfunction (heart, lungs, kidneys)
- History of malignancy other than HCC
- HBsAg and anti-HCV antibody positive concurrently
- Human immunodeficiency virus (HIV) infected
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@126.com
Kangshun Zhu, Dr.
About this study
Official title: Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
Read the detailed description
This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.
30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up to 24 months, or 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. Lenvatinib will 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.
The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Lenvatinib, sintilimab plus SIRT
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Sintilimab, 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, sintilimab plus SIRTDrug
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Len-Sin-SIRT | Experimental | Lenvatinib, sintilimab plus SIRT Receives: Drug: Lenvatinib, sintilimab plus SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) according to mRECIST
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 2.5 years
Secondary outcomes (5)
Progression free survival (PFS) according to RECIST 1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 2.5 years
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 and RECIST 1.1
Measured: 2.5 years
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Measured: 2.5 years
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause.
Measured: 2.5 years
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE v5.0.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start10 Aug 2023
- Primary completion9 Jan 2026 (estimated)
- Study completion9 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992584
- Sponsor's protocol ID
- MIIR-14
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
- ClinicalTrials.gov ID
- NCT05992584
- Acronym / sponsor ID
- MIIR-14
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Sintilimab, Yttrium-90
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 9 Jan 2026 (estimated)
- Study completion
- 9 Aug 2026 (estimated)
- First posted
- 15 Aug 2023 (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, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
Detailed description
This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.
30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up to 24 months, or 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. Lenvatinib will 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.
The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Len-Sin-SIRT | Experimental | Drug: Lenvatinib, sintilimab plus SIRTLenvatinib, sintilimab plus SIRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 session of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Key exclusion criteria (15 listed)
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
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, sintilimab plus SIRTLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity. | Drug | Len-Sin-SIRT |
Primary outcome
Progression free survival (PFS) according to mRECIST
Time frame: 2.5 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
5 secondary outcomes
Progression free survival (PFS) according to RECIST 1.1
Time frame: 2.5 years
Objective response rate (ORR)
Time frame: 2.5 years
Disease control rate (DCR)
Time frame: 2.5 years
Overall survival (OS)
Time frame: 2.5 years
Adverse Events (AEs)
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- 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. This study is not recruiting at the moment.
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, sintilimab plus SIRT in people with Hepatocellular Carcinoma, 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 15 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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?
Results are not available in the source record.
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?
Progression free survival (PFS) according to mRECIST (time frame: 2.5 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 14 Sep 2023.