Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SARS CoV-2, Liver Tumours. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.
Primary outcome measures
- The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests. [Time frame: From enrollement to 24 weeks]
Eligibility criteria
Inclusion criteria
Line 1: - Age >18 at time of signing informed consent form
- Signed informed consent form Line 2: - Primery liver tumor
- Age >18 at time of signing informed consent form
- Signed informed consent form
Exclusion criteria
Line 1: - Active or history of neoplastic malignancy
- Active autoimmune disease ongoing treatment with immunosuppressive therapy
- Evidence of positive HIV, HCV, HBV test
- Diabetes
- Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
- Chronic autoimmune or inflammatory diseases
- Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
- Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for >3 years prior to signing informed consent and considered low risk of relapse
- HIV infection
- Failure to sign informed consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia
Identifiers
NCT: NCT06914635 · 0047354/23