HIV-positive patients with advanced HCC MedDRA version: 14.1 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: NEXAVAR*112CPR RIV 200MG
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration number: 200-
Trade Name: TELZIR*1FL 60CPR RIV 700MG
Pharmaceutical Form:
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV infection serologically proven 2. HCC cytologically/histologically proven or diagnosed according to AASLD guidelines for whom invasive treatment modalities (resection, loco-regional therapies) are not indicated (57). 3. Child–Pugh score A and B7 4. Age = 18 years 5. ECOG Performance Status = 2 6. Life expectancy of at least 12 weeks 7. Presence at least of one measurable lesion according to mRECIST criteria (95). Lesions must be measured by CT-scan or MRI. 8. CD4 counts > 100 cells/µL and HIV viral load =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension 2. Active clinically serious infections (> grade 2 NCI-CTC version 4.0) 3. Active AIDS-defining infections within the last 6 months or other active AIDS-defining diseases (according to CDC Classification system for HIV infection) including patients with Kaposi sarcoma 4. Patients with CD4 counts 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) 8. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) 9. History of organ allograft or autologous transplant 10. Patients with evidence or history of bleeding diathesis 11. Patients with clinically significant GI bleeding within 30 days prior to study entry 12. Renal failure requiring dialysis 13. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of sorafenib in HCC patients with HIV receiving PI-based HAART regimens.;Primary end point(s): The primary efficacy endpoint is Time to Progression (TTP). TTP will be evaluated according to mRECIST criteria(95) in all patients treated in Step A and Step B.;Secondary Objective: To assess: STEP A and STEP B: • Overall Survival • OS rate at 6 months • Evaluation of Response Rate (RR) • Evaluation of impact on HIV infection (HIV-RNA viral load, CD4-CD8 counts) • Evaluation of Quality of life (FACT-Hep) • Evaluation of the role of innate immunity (receptors of NK and TNK cells) and adaptive immunity (interferon-class I and immuno-complexes) in relationship to clinical response and HCV viral load in HCV co-infected patients. • Evaluation of serum proteomic profile and 2D-DIGE approaches in relationship to drug toxicity and clinical response | — |
Countries
Italy
Outcome results
None listed