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OpenTrials
Completed

NCT Number: NCT01251458

Hepatocellular Carcinoma (HCC)_Torisel_

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

torisel

Drug

Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2010
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.