Hepatocellular CarcinomaThalenNCT04531228
TACE-HAIC Plus Lenvatinib for Patients With Unresectable HCC: an Open-label, Single-arm, Phase 2 Trial
A study testing TACE-HAIC plus lenvatinib in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Yunfei Yuan at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transarterial Chemoembolization
- What is being tested?
- TACE-HAIC plus lenvatinib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2020to 30 Aug 2023
- 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 17 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18-75 years
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- unresectable disease, stage BCLC B/C
- No previous anti-HCC treatment
- Eastern Co-operative Group performance status 2 or less
- Liver function: Child's A or B (score < 7)
Who cannot join
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- underlying serve cardiac or renal diseases
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Patients ineligible for hepatic artery embolization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yunfei Yuan, +862087343118, yuanyf@mail.sysu.edu.cn
About this study
Official title: Sun Yat-sen University Cancer Center
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for early-stage and well reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of unresectable HCC. TACE has been proved to provide outstanding efficacy for treating advanced stage HCC patients. However, TACE is associated with a high rate of treatment failure for advanced HCC patients. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate in our previous study.
Levatinib is a new treatment and offers relative high overall response rate for advanced HCC, which was approved in China and Japan. However, whether the combination of TACE-HAIC and Lenvatinib would increse tumor control for unresectable patients is still unknown. Thus, this single arm, phase 2 study is designed to analyze the safety and efficacy TACE-HAIC plus Lenvatinib for patients with unresectalbe HCC.
- Being tested
- TACE-HAIC plus 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.
TACE-HAIC plus lenvatinibProcedure or surgery
chemo-lipiodolization with EADM (30mg/m2), followed by FOLFOX-based chemotherapy artery infusion (Oxa 85mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2). Lenvatinib was administrated two or four days after TACE-HAIC, with 8mg for patients weight <60kg, or 12mg for patients weight more than 60Kg.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TACE-HAIC plus lenvatinib | Experimental | chemo-lipiodolization, followed by FOLFOX-based chemotherapy artery infusion (HAIC). Lenvatinib was administrated two or four days after TACE-HAIC. Receives: Procedure: TACE-HAIC plus lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
the time from assignment to progression, death or last follow-up.
Measured: 6-12 months
Secondary outcomes (3)
overall survival
the time from assignment to death or last follow-up
Measured: 6-12 months
overall response rate
Objective response rate defined as confirmed complete response or partial response under mRECIST 1.1 criteria
Measured: 6-12 months
adverse effects
Frequency and severity of adverse effects as defined by CTCAE version 5
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start11 Oct 2020
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Aug 2023 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunfei Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunfei Yuan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531228
- Sponsor's protocol ID
- B2020-137
- Acronym
- Thalen
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2020
- Last updated
- 22 Sep 2021
- 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 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Yat-sen University Cancer Center
- ClinicalTrials.gov ID
- NCT04531228
- Acronym / sponsor ID
- Thalen / B2020-137
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yunfei YuanUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 28 Aug 2020 (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.
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for early-stage and well reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of unresectable HCC. TACE has been proved to provide outstanding efficacy for treating advanced stage HCC patients. However, TACE is associated with a high rate of treatment failure for advanced HCC patients. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate in our previous study.
Levatinib is a new treatment and offers relative high overall response rate for advanced HCC, which was approved in China and Japan. However, whether the combination of TACE-HAIC and Lenvatinib would increse tumor control for unresectable patients is still unknown. Thus, this single arm, phase 2 study is designed to analyze the safety and efficacy TACE-HAIC plus Lenvatinib for patients with unresectalbe HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: TACE-HAIC plus lenvatinib | Experimental | Procedure: TACE-HAIC plus lenvatinibchemo-lipiodolization, followed by FOLFOX-based chemotherapy artery infusion (HAIC). Lenvatinib was administrated two or four days after TACE-HAIC. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years
Key exclusion criteria (4 listed)
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
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-HAIC plus lenvatinibchemo-lipiodolization with EADM (30mg/m2), followed by FOLFOX-based chemotherapy artery infusion (Oxa 85mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2). Lenvatinib was administrated two or four days after TACE-HAIC, with 8mg for patients weight <60kg, or 12mg for patients weight more than 60Kg. | Procedure or surgery | Experimental: TACE-HAIC plus lenvatinib |
Primary outcome
progression-free survival
Time frame: 6-12 months
the time from assignment to progression, death or last follow-up.
3 secondary outcomes
overall survival
Time frame: 6-12 months
overall response rate
Time frame: 6-12 months
adverse effects
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- 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.
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-HAIC plus lenvatinib in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Yunfei Yuan 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 6 inclusion and 4 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 22 Sep 2021. 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 Jiliang Qiu (+862087342654, qiujl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 6-12 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 22 Sep 2021.