ivolumab after selective internal radiation therapy using SIR-Spheres to treat patients with primary liver cancer: a safety and efficacy study
- Conditions
- Hepatocellular carcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000232-34-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
Age 18-years-old or above
Diagnosis of HCC based on histology or non-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded.
Chronic liver disease absent, non-viral or due to hepatitis C or B virus infection. Subjects with chronic HBV infection must be on effective antiviral therapy
Preserved liver function (without cirrhosis or with compensated cirrhosis in Child Pugh Class A).
ECOG performance status 0 or 1
Willing to have a liver biopsy pre-treatment
Considered candidates for locoregional therapy using SIR-Spheres based on
•the absence of extrahepatic disease.
•unsuitability for liver resection or transplantation, or percutaneous ablation
•considered not good candidates for TACE because they have:
oSingle tumors larger than 5 cm. Unsuitability for TACE in patients with single tumors of size between 5 and 10 cm will follow local practice in the treating center.
oMultiple tumors that cannot be targeted superselectively. These patients should be in the BCLC-B2 substage proposed by Bolondi et al (3). In summary, they should fall within the up-to-7 rule (the sum of the number of tumors and the maximal size of the largest lesion in cm should be higher than 7) and should be in a Child-Pugh stage A. Unsuitability for TACE in patients with multiple tumors within the BCLC-B2 substage will follow local practice in the treating center.
oUnilobar tumors with segmental or lobar portal vein thrombosis. Patients that have a small burden of disease (< 10% of the total tumor burden) in the contralateral lobe may be treated at the discretion of the site Principal Investigator
At least one measurable lesion by RECIST 1.1 criteria.
Adequate organ and marrow function as evidenced by:
•WBC = 2000/µL.
•Neutrophils = 1000/µL.
•Platelets = 60 x 103/µL.
•Hemoglobin = 9.0 g/dL.
•Creatinine CrCl >40 mL/min.
•AST and ALT = 5 X ULN
•Bilirubin = 2 mg/dL
•INR = 1.8.
•Albumin = 2.8 g/dL
Willing and able to comply with immune-monitoring sample collection and required study follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Any history of hepatic encephalopathy
Any prior (within 1 year) or current clinically significant ascites.
Any history of clinically meaningful variceal bleeding within the last three months.
Active coinfection with both hepatitis B and C or hepatitis D infection in subjects with hepatitis B
Occlusive main trunk portal vein thrombosis or absence of intrahepatic portal blood flow if patient carries a portocaval shunt.
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Any active autoimmune disease.
Any severe organ disease
Prior therapy with any drug specifically targeting T-cell costimulation or checkpoint pathways.
Prior organ allograft or allogeneic bone marrow transplantation
Recent active bacterial or fungal infections.
Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method