Hepatocellular Carcinoma (HCC)_Torisel_

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251458
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Brief Summary:
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel

Condition or disease Intervention/treatment Phase
Inoperable HCC Drug: Torisel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression
Study Start Date : October 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Torisel Drug: Torisel
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

Primary Outcome Measures :
  1. • To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC [ Time Frame: 2 Years ]
  2. • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel® [ Time Frame: 4 Years ]
  3. • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel® [ Time Frame: 2 years ]
  4. • To determine the response rate (CR and PR) based on RECIST criteria [ Time Frame: 2 years ]
  5. • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks) [ Time Frame: 2 years ]
  6. • To determine duration of response (DR) [ Time Frame: 2 years ]
  7. • To determine overall survival (OS) [ Time Frame: 4 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
  • measurable disease
  • Age >=18 years.
  • Life expectancy of greater than 12 weeks.
  • ECOG performance status <= 2
  • Prior systemic therapy for HCC is allowed
  • Adequate haematologic, renal and hepatic function
  • Absence of cirrhosis or Child's A cirrhosis
  • Fasting total cholesterol <9.1 mmol/liter and fasting triglyceride level <4.5 mmol/liter)

Exclusion Criteria:

  • Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
  • Patients receiving any other investigational agents concurrently.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251458

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Winnie Yeo, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT01251458     History of Changes
Other Study ID Numbers: HCC022
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents