Clinical trial · Interventional
Hepatocellular Carcinoma (HCC)_Torisel_
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
NCT01251458CI-TRIAL-00024072completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inoperable HCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Torisel | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Torisel
- interventionNames
- Drug: Torisel
Primary outcomes (1)
- measure
- • 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)
- timeFrame
- 2 years
Secondary outcomes (7)
- measure
- • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC
- timeFrame
- 2 Years
- measure
- • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.