Status:
COMPLETED
A Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT for the Treatment of Patients With HCC
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
Sirtex Medical
Bristol-Myers Squibb
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of the anti-programmed death 1 (PD-1) agent nivolumab following selective internal radiation therapy (SIRT) for patients with unresectable hepatocel...
Detailed Description
Worldwide, intra-arterial therapies are the mainstay of the treatment of patients with HCC in the intermediate stage or in the advanced stage because of portal vein invasion. While transarterial chemo...
Eligibility Criteria
Inclusion
- Diagnosis of HCC based on histology or non-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded.
- Cirrhosis absent, non-viral or due to hepatitis C or B virus infection. Subjects with chronic hepatitis B virus 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 (patients with regional lymph nodes \< 2 cm in short axis are accepted)
- unsuitability for liver resection or transplantation, or percutaneous ablation
- considered not good candidates for TACE because they have; Single tumors larger than 5 cm. Multiple tumors that cannot be targeted superselectively. Unilobar tumors with segmental or lobar portal vein thrombosis.
- At least one measurable lesion by RECIST 1.1 criteria.
- Adequate organ and marrow function as evidenced by:
- White blood cell count ≥ 2000/μL.
- Neutrophils ≥ 1000/μL.
- Platelets ≥ 60 x 103/μL.
- Hemoglobin ≥ 9.0 g/dL.
- Creatinine Clearance \> 40 mL/min.
- AST and ALT ≤ 5 X ULN
- Bilirubin ≤ 2 mg/dL
- INR ≤ 1.8.
- Albumin ≥ 3.0 g/dL
- Willing and able to comply with immune-monitoring sample collection and required study follow-up.
Exclusion
- Any history of hepatic encephalopathy
- Any prior (within 6 months) or current clinical 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 autoimmune disease that may require immunosuppressive therapy.
- 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
- Active bacterial or fungal infections within 7 days of study entry.
- Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03380130
Start Date
September 11 2017
End Date
November 4 2020
Last Update
November 4 2020
Active Locations (9)
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1
Hospital Universitario de Cruces
Barakaldo, Spain
2
Hospital Clinic
Barcelona, Spain
3
Hospital Universitario 12 de Octubre
Madrid, Spain
4
Hospital Universitario Gregorio Marañon
Madrid, Spain