Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by

About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Hepatocellular carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lenalidomide
Arm Description
Outcomes
Primary Outcome Measures
disease stabilization
Secondary Outcome Measures
Full Information
NCT ID
NCT01545804
First Posted
March 1, 2012
Last Updated
February 7, 2017
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01545804
Brief Title
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma
Official Title
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma (HCC): a Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Hepatocellular carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
All enrolled patients will receive Lenalidomide, 25 mg orally daily, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
Primary Outcome Measure Information:
Title
disease stabilization
Time Frame
8 weeks until tumor progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiun Hsu, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28815645
Citation
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.
Results Reference
derived
Learn more about this trial
Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma
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