Liver CancerPhase 2NCT01545804
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma
A Phase 2 study testing Lenalidomide in people with Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Dec 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed HCC, OR clinically diagnosed HCC
- Documented progression with or intolerance to first-line molecular targeted therapy as first-line therapy for advanced HCC.
- Acceptable first-line molecular targeted therapies include (1) sorafenib monotherapy and sorafenib-based combination; (2) anti-angiogenic therapy including brivanib, linifanib, pazopanib, bevacizumab, dovitinib (TKI258), and vargatef (BIBF1120).
- For patients who receive first-line sorafenib monotherapy or sorafenib-based combination, patients must have received at least 14 days of sorafenib treatment with the lowest dosage of 400 mg per day.
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
- ECOG performance status 0 or 1.
- Child-Pugh class A liver function.
Who cannot join
- Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, chemotherapy, or other experimental therapy.
- Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy administered within 4 weeks prior to enrollment.
- History of HCC tumor rupture.
- Presence of brain or leptomeningeal metastases.
- Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
- History of upper gastrointestinal bleeding within 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma (HCC): a Phase II Clinical Trial
This is a single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.
Read the detailed description
This is a single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of HCC, advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC, ECOG performance status 0 or 1, Child-Pugh class A liver function, and measurable tumors (by RECIST 1.1). All enrolled patients will receive lenalidomide, starting at 25 mg orally daily on days 1-21, every 4 weeks. Lenalidomide treatment will continue until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events. Tumor assessment will be done after 4 weeks and 8 weeks of treatment and every 8 weeks thereafter until objective disease progression. All patients will receive DCE-MRI at baseline, on day 3 ± 1 day, and on day 14 ± 2 days. The primary endpoint is the percentage of patients who are tumor progression-free (according to RECIST 1.1) at 6 months after lenalidomide treatment. It is estimated that in the 2nd-line setting, 20% or less patients will remain progression-free at 6 months with current treatment, i.e., no standard treatment. Lenalidomide will be considered effective if the percentage of patients who remain progression-free at 6 months can be increased to 40%. With type I and type II errors of 0.05 and 0.1, respectively, 50 evaluable patients, i.e., patients who receive at least 4 weeks of study medication and receive the first scheduled assessment of tumor response, will be required and the planned sample size will be 55 patients, assuming a 10% dropout rate. The study is expected to complete in 2 years.
- Conditions
- Liver Cancer
- Being tested
- Lenalidomide
- Keywords
- Hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
All enrolled patients will receive Lenalidomide, 25 mg orally daily, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease stabilization
Measured: 8 weeks until tumor progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiun Hsu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545804
- Sponsor's protocol ID
- 201105063MB
- Status last verified
- Feb 2017
- First submitted
- 1 Mar 2012
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Shao YY, Chen BB, Ou DL, Lin ZZ, Hsu CH, Wang MJ, Cheng AL, Hsu C. Lenalidomide as second-line therapy for advanced hepatocellular carcinoma: exploration of biomarkers for treatment efficacy. Aliment Pharmacol Ther. 2017 Oct;46(8):722-730. doi: 10.1111/apt.14270. Epub 2017 Aug 17.
PubMed 28815645
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma (HCC): a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT01545804
- Acronym / sponsor ID
- 201105063MB
- Conditions
- Liver Cancer
- Keywords
- Hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Mar 2012 (estimated)
- 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 single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.
Detailed description
This is a single-arm, open-label phase II trial. Eligible patients must have histological or clinical diagnosis of HCC, advanced tumors that are not amenable to loco-regional therapy, documented progression with or intolerance to sorafenib-based treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC, ECOG performance status 0 or 1, Child-Pugh class A liver function, and measurable tumors (by RECIST 1.1). All enrolled patients will receive lenalidomide, starting at 25 mg orally daily on days 1-21, every 4 weeks. Lenalidomide treatment will continue until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events. Tumor assessment will be done after 4 weeks and 8 weeks of treatment and every 8 weeks thereafter until objective disease progression. All patients will receive DCE-MRI at baseline, on day 3 ± 1 day, and on day 14 ± 2 days. The primary endpoint is the percentage of patients who are tumor progression-free (according to RECIST 1.1) at 6 months after lenalidomide treatment. It is estimated that in the 2nd-line setting, 20% or less patients will remain progression-free at 6 months with current treatment, i.e., no standard treatment. Lenalidomide will be considered effective if the percentage of patients who remain progression-free at 6 months can be increased to 40%. With type I and type II errors of 0.05 and 0.1, respectively, 50 evaluable patients, i.e., patients who receive at least 4 weeks of study medication and receive the first scheduled assessment of tumor response, will be required and the planned sample size will be 55 patients, assuming a 10% dropout rate. The study is expected to complete in 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically diagnosed HCC, OR clinically diagnosed HCC
- Documented progression with or intolerance to first-line molecular targeted therapy as first-line therapy for advanced HCC.
- Acceptable first-line molecular targeted therapies include (1) sorafenib monotherapy and sorafenib-based combination; (2) anti-angiogenic therapy including brivanib, linifanib, pazopanib, bevacizumab, dovitinib (TKI258), and vargatef (BIBF1120).
- For patients who receive first-line sorafenib monotherapy or sorafenib-based combination, patients must have received at least 14 days of sorafenib treatment with the lowest dosage of 400 mg per day.
- At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
Key exclusion criteria (6 listed)
- Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, chemotherapy, or other experimental therapy.
- Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy administered within 4 weeks prior to enrollment.
- History of HCC tumor rupture.
- Presence of brain or leptomeningeal metastases.
- Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of 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 |
|---|---|---|
| LenalidomideAll enrolled patients will receive Lenalidomide, 25 mg orally daily, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects. | Drug | Lenalidomide |
Primary outcome
disease stabilization
Time frame: 8 weeks until tumor progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 28815645Shao YY, Chen BB, Ou DL, Lin ZZ, Hsu CH, Wang MJ, Cheng AL, Hsu C. Lenalidomide as second-line therapy for advanced hepatocellular carcinoma: exploration of biomarkers for treatment efficacy. Aliment Pharmacol Ther. 2017 Oct;46(8):722-730. doi: 10.1111/apt.14270. Epub 2017 Aug 17.
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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.
Chiun Hsu, MD, PhD principal investigator
National Taiwan University Hospital
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 Lenalidomide in people with Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 9 Feb 2017. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease stabilization (time frame: 8 weeks until tumor progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545804, which also lists 1 linked publication.
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 9 Feb 2017.