Actively Recruiting
Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2024-08-21
27
Participants Needed
4
Research Sites
209 weeks
Total Duration
On this page
Sponsors
C
CNAO National Center of Oncological Hadrontherapy
Lead Sponsor
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response. Considering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care.
CONDITIONS
Official Title
Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Histologic confirmation of malignancy treated with single-agent anti-PD1/PDL1 immunotherapy approved by Italian authorities
- Disease stability as assessed by regulatory monitoring
- At least two measurable lesions, with one suitable for carbon ion radiotherapy
- Ability and willingness to comply with study visits, treatments, and tests
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 2 or less
- Measurable disease by CT or MRI according to RECIST 1.1 criteria
You will not qualify if you...
- Treatment with chemo-immunotherapy combinations
- Treatment with immunotherapy combinations (e.g., anti-CTLA4 plus anti-PD1/PDL1)
- Receiving immunotherapy within clinical trials
- Receiving off-label immunotherapy or expanded access programs
- High tumor burden (more than 10 lesions or total diameter greater than 19 cm)
- Metastases located only in the central nervous system
- Serious or uncontrolled medical disorders that increase study risk or interfere with therapy
- Autoimmune diseases including local and systemic collagen-vascular and inflammatory bowel diseases
- Previous radiotherapy on the selected metastatic site
- Any immune-related grade 4 adverse events before study entry
- Immune-related grade 3 or higher adverse events within 3 weeks before carbon ion radiotherapy
- Metal prostheses or conditions preventing adequate imaging for treatment planning
- Local infections or conditions preventing hadron therapy
- Prisoners or involuntarily incarcerated individuals
- Compulsorily detained for psychiatric or physical illness treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
GSI Helmholtzzentrum für Schwerionenforschung GmbH
Darmstadt, Germany
Active, Not Recruiting
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Actively Recruiting
3
National Center for Oncological Hadrontherapy (CNAO)
Pavia, Italy, 27100
Not Yet Recruiting
4
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
Research Team
C
Chiara Campo, PhD
CONTACT
C
Cristina Bono
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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