Clinical trial · Interventional
Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)
NCT01079767CI-TRIAL-00013931terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study treminated early according to DSMB recommendantions
Summary
Brief summary (as posted)
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Temsirolimus
- description
- Temsirolimus
- interventionNames
- Drug: temsirolimus
Primary outcomes (1)
- measure
- 3-month disease-control rate according to RECIST criteria
- timeFrame
- 2010
Secondary outcomes (1)
- measure
- 3-month objective response rate according to RECIST criteria
- timeFrame
- 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria * Advanced disease * Must be morphologically evaluable * HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy * CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume) * Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria: * Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy * Not a candidate for transplantation and has not received a liver transplant PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Platelet count ≥ 50,000/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Creatinine clearance ≥ 60 mL/min * GFR ≥ 30 mL/min * Serum cholesterol ≤ 350 mg/dL * Triglycerides ≤ 300 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy * No history of other cancer on treatment * No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction * No active infection except for viral hepatitis * No HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5 * At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC * At least 6 months since prior chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.