This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:
1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion. 2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months. 3. Assess Local control up to 12 months after DaRT insertion.
1. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
Platelets ≥100,000 mm3,
Total bilirubin ≤ 1.5xULN,
AST ≤2.5xULN,
1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
Antineoplastic systemic chemotherapy or biological therapy
Immunotherapy
Investigational agents other than the study intervention
Single group
DaRT seeds
DeviceDiffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
objective response rate
• Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
Progression Free Survival
• Determine Progression Free Survival (PFS) up to 12 months after DaRT seed insertion.
Overall Survival
• Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
Local control
• Assess Local control up to 12 months after DaRT insertion.
Safety Objectives
Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5.
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