Hepatocellular Carcinoma Non-resectableNCT04967495
TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT
A study testing TACE combined with lenvatinib and iodion-125 seeds brachytherapy and TACE combined with 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 transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT). 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?
- TACE combined with lenvatinib and iodion-125 seeds brachytherapy and TACE combined with lenvatinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 8 Jan 2025
- Phase
- Interventional
- 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
- Age between18 and 75 years.
- HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
- Accompanied with tumor thrombus involving unilateral portal vein branch.
- Child-Pugh class A or B.
- Eastern Cooperative Group performance status (ECOG) score of 0-2.
- Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
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- Prothrombin time prolonged for less than 4s or international normalized ratio < 1.7.
- Neutrophilic granulocyte count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L, and hemoglobin level ≥ 85g/L;
- At least one measurable intrahepatic target lesion.
- Life expectancy of at least 3 months.
Who cannot join
- Diffuse HCC.
- Extrahepatic metastasis.
- Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
- Hepatic vein and/or vena cava invasion.
- History of organ or cells transplantation.
- Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
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- History of other malignancies.
- Serious medical comorbidities.
- Female patients who are pregnancy or breastfeeding.
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
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
About this study
Official title: Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
Read the detailed description
This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.
171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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 TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- TACE combined with lenvatinib and iodion-125 seeds brachytherapy, TACE combined with lenvatinib
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Tyrosine kinase inhibitor, iodion-125 seed
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE combined with lenvatinib and iodion-125 seeds brachytherapyProcedure or surgery
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
TACE combined with lenvatinibProcedure or surgery
TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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.
| Study group | Role | What they receive |
|---|---|---|
| TACE-Len-I | Experimental | TACE combined with lenvatinib and iodion-125 seeds brachytherapy Receives: Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapy |
| TACE-Len | Active comparator | TACE combined with lenvatinib Receives: Procedure: TACE combined with lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from date of randomization to death due to any cause.
Measured: 2 years.
Secondary outcomes (5)
Adverse events (AEs)
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Measured: 2 years.
Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)
The time from date of randomization until the first occurrence of disease progression (PD) or death due to any cause, whichever occurs first.
Measured: 2 years.
Objective response rate (ORR) assessed by investigators according to mRECIST
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Measured: 2 years.
Disease control rate (DCR) assessed by investigators according to mRECIST
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
Measured: 2 years.
Duration of portal patency
The time from randomization until the date that complete portal vein occlusion was confirmed.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start9 Jul 2021
- Primary completion8 Jan 2025 (estimated)
- Study completion8 Jan 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967495
- Sponsor's protocol ID
- MIIR-07
- Status last verified
- May 2023
- First submitted
- 8 Jul 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail
- ClinicalTrials.gov ID
- NCT04967495
- Acronym / sponsor ID
- MIIR-07
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Tyrosine kinase inhibitor, iodion-125 seed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 8 Jan 2025 (estimated)
- Study completion
- 8 Jan 2025 (estimated)
- First posted
- 19 Jul 2021 (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 transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
Detailed description
This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.
171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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 TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE-Len-I | Experimental | Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapyTACE combined with lenvatinib and iodion-125 seeds brachytherapy |
| TACE-Len | Active comparator | Procedure: TACE combined with lenvatinibTACE combined with lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between18 and 75 years.
- HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
- Accompanied with tumor thrombus involving unilateral portal vein branch.
- Child-Pugh class A or B.
- Eastern Cooperative Group performance status (ECOG) score of 0-2.
Key exclusion criteria (9 listed)
- Diffuse HCC.
- Extrahepatic metastasis.
- Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
- Hepatic vein and/or vena cava invasion.
- History of organ or cells 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 |
|---|---|---|
| TACE combined with lenvatinib and iodion-125 seeds brachytherapyTACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. | Procedure or surgery | TACE-Len-I |
| TACE combined with lenvatinibTACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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. | Procedure or surgery | TACE-Len |
Primary outcome
Overall survival (OS)
Time frame: 2 years.
The time from date of randomization to death due to any cause.
5 secondary outcomes
Adverse events (AEs)
Time frame: 2 years.
Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)
Time frame: 2 years.
Objective response rate (ORR) assessed by investigators according to mRECIST
Time frame: 2 years.
Disease control rate (DCR) assessed by investigators according to mRECIST
Time frame: 2 years.
Duration of portal patency
Time frame: 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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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 study testing TACE combined with lenvatinib and iodion-125 seeds brachytherapy and TACE combined with 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: status not confirmed, as of the sponsor's last update on 18 May 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.
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?
Overall survival (OS) (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 18 May 2023.