Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01545804
First received: March 1, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lenalidomide as Second-line Treatment for Advanced Hepatocellular Carcinoma (HCC): a Phase II Clinical Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • disease stabilization [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide Drug: Lenalidomide
All enrolled patients will receive Lenalidomide, 25 mg orally daily, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
Other Name: Lenalidomide

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545804

Contacts
Contact: Chiun Hsu, MD, PhD 886-2-23123456 ext 67009 chsu1967@ntu.edu.tw
Contact: Shu-Hui Lin, BA 886-2-23123456 ext 63467 anjeli@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chiun Hsu, MD, PhD    886-2-23123456 ext 67009    chsu1967@ntu.edu.tw   
Principal Investigator: Chiun Hsu, MD, PhD         
Sub-Investigator: Ann-Lii Cheng, MD,PhD         
Sub-Investigator: Chih-Hung Hsu, MD, PhD         
Sub-Investigator: Zhong-Zhe Lin, MD         
Sub-Investigator: Ying-Chun Shen, MD         
Sub-Investigator: Ting-Fang Shih, MD         
Sub-Investigator: Pei-Jer Chen, MD, PhD         
Sub-Investigator: Bang-Bin Chen, MD         
Sub-Investigator: Yu-Yun Shao, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chiun Hsu, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01545804     History of Changes
Other Study ID Numbers: 201105063MB
Study First Received: March 1, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Taiwan University Hospital:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014