Liver TumorPhase 2NCT05555316
TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
A Phase 2 study testing TACE combined with Lenvatinib in people with Liver Tumor, run by Sun Yat-sen University at 1 site in China.
Trial summary
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Tumor
- What is being tested?
- TACE combined with Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2019to Nov 2023
- 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
- Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months;
- Number of tumors ≤ 3;
- Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
- Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus;
- Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked;
- Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
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- No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
- Leukocyte count ≥ 3.0 × 109/L；
- Hemoglobin ≥ 8.5g/dl;
- Platelet count ≥ 50 × 109/L；
- The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds;
- Serum creatinine was less than 1.5 times of the upper limit of normal;
- Patients and / or family members agree to join the clinical trial and sign the informed consent form
Who cannot join
- Diffuse hepatocellular carcinoma;
- Portal vein tumor thrombus;
- Combined with tumor thrombus of hepatic vein and inferior vena cava;
- Patients with lymph node metastasis and extrahepatic distant metastasis;
- The liver function was classified as child Pugh C and could not be improved by liver protection treatment;
- Arteriovenous fistula or arterioportal fistula with ineffective intervention;
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- Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency;
- Intractable massive ascites;
- ECoG physical fitness score > 2 points;
- Combined with active infection, especially bile duct inflammation;
- Serious heart, lung, kidney, brain and other important organ diseases;
- Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jinhua Huang, Ph.D, 0086-20-87343447, huangjh@sysucc.org.cn
Jinhua Huang, Ph.D
About this study
Official title: Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
Read the detailed description
The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.
- Conditions
- Liver Tumor
- Being tested
- TACE combined with Lenvatinib
- Keywords
- Large hepatocellular carcinoma, Lenvatinib, TACE, Microwave ablation
- 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 LenvatinibDrug
Also called lenvima
Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). Lenvatinib reduction standard: 8mg / day; 4mg / day; 4mg, the next day.
| Study group | Role | What they receive |
|---|---|---|
| TACE combined with Lenvatinib | Experimental | Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). Receives: Drug: TACE combined with Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Down stage rate
if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.
Measured: 4 months
Secondary outcomes (4)
RFS
Recurrence free survival indicates the length of time after MWA for a cancer ends that the patient survives without any signs or symptoms of HCC
Measured: 3 years
Objective response rate
Change of the tumor size according to the modified response evaluation criteria in solid tumors (mRECIST) [see attached table 3], the efficacy is defined as CR (complete remission), PR (partial remission), SD (stable) and PD (Progress)
Measured: 3 years
Changes of liver and kidney function
Changes of liver and kidney function index from blood biochemistry compared to baseline
Measured: 3 years
TACE frequency and ablation frequency
To access the times and frequency of TACE and ablation
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 posted26 Sep 2022
- Study start10 Nov 2019
- Primary completionJan 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Jinhua, Sun Yat-sen University
- Investigators
- Jinhua Huang, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555316
- Sponsor's protocol ID
- TALEM
- Status last verified
- Sep 2022
- First submitted
- 20 Jan 2022
- Last updated
- 26 Sep 2022
- Results posted
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05555316
- Acronym / sponsor ID
- TALEM
- Conditions
- Liver Tumor
- Keywords
- Large hepatocellular carcinoma, Lenvatinib, TACE, Microwave ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Sep 2022 (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.
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
Detailed description
The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combined with Lenvatinib | Experimental | Drug: TACE combined with LenvatinibThree days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months;
- Number of tumors ≤ 3;
- Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
- Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus;
- Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked;
Key exclusion criteria (12 listed)
- Diffuse hepatocellular carcinoma;
- Portal vein tumor thrombus;
- Combined with tumor thrombus of hepatic vein and inferior vena cava;
- Patients with lymph node metastasis and extrahepatic distant metastasis;
- The liver function was classified as child Pugh C and could not be improved by liver protection 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 |
|---|---|---|
| TACE combined with LenvatinibAlso: lenvimaThree days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). Lenvatinib reduction standard: 8mg / day; 4mg / day; 4mg, the next day. | Drug | TACE combined with Lenvatinib |
Primary outcome
Down stage rate
Time frame: 4 months
if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.
4 secondary outcomes
RFS
Time frame: 3 years
Objective response rate
Time frame: 3 years
Changes of liver and kidney function
Time frame: 3 years
TACE frequency and ablation frequency
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- 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. This study is not recruiting at the moment.
Jinhua Huang, Ph.D principal investigator
Sun Yat-sen 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 TACE combined with Lenvatinib in people with Liver Tumor, run by Sun Yat-sen 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 13 inclusion and 12 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 26 Sep 2022. 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 Jinhua Huang, Ph.D (0086-20-87343447, huangjh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Down stage rate (time frame: 4 months). 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 26 Sep 2022.