Hepatocellular CarcinomaPhase 3NCT04053985
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
A Phase 3 study testing TAI combine lenvatinib and Lenvatinib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma 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?
- TAI combine lenvatinib and Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Phase 3
- 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
- older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent
Who cannot join
- cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, 510060
Rong-Ping Guo, M.D., 00862087342266, guorp@sysucc.org.cn
Wei Wei, Ph.D. M.D., 00862087343790, weiwei@sysucc.org.cn
About this study
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TAI combine lenvatinib, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAI combine lenvatinibCombination product
TAI combine lenvatinib
LenvatinibDrug
lenvatinib only
| Study group | Role | What they receive |
|---|---|---|
| TAI+lenvatinib group | Experimental | TAI combine lenvatinib Receives: Combination Product: TAI combine lenvatinib |
| lenvatinib group | Active comparator | lenvatinib only Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
progression-free survival
Measured: From date of randomization until the date of progress from any cause, assessed up to 60 months
Secondary outcomes (2)
ORR
object response rate
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
DCR
disease control rate
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-ping Guo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053985
- Sponsor's protocol ID
- B2019-076-01
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT04053985
- Acronym / sponsor ID
- B2019-076-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Aug 2019 (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.
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAI+lenvatinib group | Experimental | Combination Product: TAI combine lenvatinibTAI combine lenvatinib |
| lenvatinib group | Active comparator | Drug: Lenvatiniblenvatinib only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent
Key exclusion criteria (1 listed)
- cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
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 |
|---|---|---|
| TAI combine lenvatinibTAI combine lenvatinib | Combination product | TAI+lenvatinib group |
| Lenvatiniblenvatinib only | Drug | lenvatinib group |
Primary outcome
OS
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
PFS
Time frame: From date of randomization until the date of progress from any cause, assessed up to 60 months
progression-free survival
2 secondary outcomes
ORR
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
DCR
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- 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 3 study testing TAI combine lenvatinib and Lenvatinib in people with Hepatocellular Carcinoma, 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 1 inclusion and 1 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 13 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of randomization until the date of death from any cause, assessed up to 60 months). The study lists 2 primary outcomes in all. 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 13 Aug 2019.