Carcinoma, HepatocellularNCT04560751
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)
An observational study of Carcinoma, Hepatocellular, run by Zhejiang Cancer Hospital.
Trial summary
This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Lenvatinib and TACE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 31 Aug 2022
- Phase
- Observational
- 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
Study population: Unrecestable CNLC stage IIb-IIIb HCC patients
Who may be able to join
- Ages of ≥ 18 and ≤ 75 years old.
- Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
- China stage IIb-IIIb patients, not suitable for surgical resection.
- The imaging examination within 2 weeks before interventional therapy showed that there was at least one target lesion that could be measured by CT or MRI, and the lesion was suitable for repeated and accurate measurement.
- Child-Pugh scores ≤7.
- ECOG：0-1.
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- Intended to be treated with TACE combined with lenvatinib.
- Good organ and bone marrow function: Blood routine: WBC>4.0×109/L、Hb>80g/L, PLT>75×109/L, NEUT>1.5×10⁹/L. Blood coagulation function: International normalized ratio (INR)<1.2. Hepatic function: serum albumin (ALB)>3.5 g/dl, total bilirubin (TBIL) <1.5 × normal upper limit (ULN) (Eliminate biliary obstruction), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × ULN. Renal dysfunction：serum creatinine (SCR) <1.5× ULN.
- Agreed to join the clinical trial and sign the informed consent form.
Who cannot join
- Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- With invasion of the main portal vein or vena cava.
- Received interventional therapy such as TACE within 2 years.
- Received systematic treatment in the past.
- Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
- Patients with hypertension who cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure > 140mmHg, or diastolic blood pressure > 90 mmHg).
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- Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia or myocardial ischemia or myocardial infarction (The QTc interval ≥ 450ms, QTc interval is calculated by Fridericia formula).
- There is a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding in the past 3 months, such as esophageal varices at risk of bleeding, local active ulcer lesions, fecal occult blood ≥ (+).
- Pregnant or lactating women. A fertile patient who is unwilling or unable to use effective contraception.
- Patients with HIV infection.
- Suspected allergy to research drugs.
- Other situations which the researchers considered ineligible for participating in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma：A Multicenter, Single-armed, Prospective, Observational Study (Prolong)
This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past.
Read the detailed description
Only 30% of HCC patients received radical resection. Most of the patients are in the advanced stage and can only receive palliative treatment such as TACE or systemic treatment. Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT and showed significant anti-tumor effect in REFLECT study. The purpose of this study is to explore the efficacy and safety of Lenvatinib and TACE in unresectable HCC patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Lenvatinib, TACE
- Keywords
- Transarterial chemoembolization, Lenvatinib, Carcinoma, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib capsules will be administered orally, once daily (for patients <60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po)
TACEProcedure or surgery
TACE will be performed as needed.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib and TACE | Patients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE. Receives: Drug: Lenvatinib; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: up to 12 months
Secondary outcomes (5)
Intrahepatic ORR and Extrahepatic ORR
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST intrahepatic or extrahepatic, respectively.
Measured: up to 12 months
Progression-free survival (PFS)
The time from the beginning of treatment of TACE to the time of tumor progression or death from any cause (according to mRECIST standard)
Measured: up to 12 months
Alpha-fetoprotein (AFP) response rate
A decrease in AFP of more than 20% in AFP+ patients treated with lenvatinib is defined as an AFP response.AFP response rate defined as the percentage of AFP response patients in all AFP positive patients.
Measured: up to 12 months
Time to progression（TTP）
The time from the beginning of treatment of TACE to the time of tumor progression. (according to mRECIST standard)
Measured: up to 12 months
Adverse events(AEs)
AEs(adverse events) evaluated by the CTC-AE 5.0
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start30 Sep 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guoliang shao, Zhejiang Cancer Hospital
- Investigators
- Guoliang Shao, Professor, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560751
- Sponsor's protocol ID
- Prolong
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma：A Multicenter, Single-armed, Prospective, Observational Study (Prolong)
- ClinicalTrials.gov ID
- NCT04560751
- Acronym / sponsor ID
- Prolong
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Transarterial chemoembolization, Lenvatinib, Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Sep 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.
This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past.
Detailed description
Only 30% of HCC patients received radical resection. Most of the patients are in the advanced stage and can only receive palliative treatment such as TACE or systemic treatment. Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT and showed significant anti-tumor effect in REFLECT study. The purpose of this study is to explore the efficacy and safety of Lenvatinib and TACE in unresectable HCC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib and TACE | – | Drug: Lenvatinib, Procedure: TACEPatients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unrecestable CNLC stage IIb-IIIb HCC patients
Key inclusion criteria (9 listed)
- Ages of ≥ 18 and ≤ 75 years old.
- Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
- China stage IIb-IIIb patients, not suitable for surgical resection.
- The imaging examination within 2 weeks before interventional therapy showed that there was at least one target lesion that could be measured by CT or MRI, and the lesion was suitable for repeated and accurate measurement.
- Child-Pugh scores ≤7.
Key exclusion criteria (12 listed)
- Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- With invasion of the main portal vein or vena cava.
- Received interventional therapy such as TACE within 2 years.
- Received systematic treatment in the past.
- Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
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 |
|---|---|---|
| LenvatinibLenvatinib capsules will be administered orally, once daily (for patients <60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po) | Drug | Lenvatinib and TACE |
| TACETACE will be performed as needed. | Procedure or surgery | Lenvatinib and TACE |
Primary outcome
Objective response rate（ORR）
Time frame: up to 12 months
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST.
5 secondary outcomes
Intrahepatic ORR and Extrahepatic ORR
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Alpha-fetoprotein (AFP) response rate
Time frame: up to 12 months
Time to progression（TTP）
Time frame: up to 12 months
Adverse events(AEs)
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- 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.
Guoliang Shao, Professor study chair
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Zhejiang Cancer Hospital.
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 9 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Guoliang Shao, Professor (13989898089, zenghuiray@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: up to 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 23 Sep 2020.