Status:
COMPLETED
Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Renal Cell Carcinoma
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Renal cell carcinoma (RCC) is the sixth most common cancer in men and the eighth in women in the USA. In Italy RCC incidence was 11500 new cases in 2017, while mortality was 3371 cases in 2015. Increa...
Detailed Description
Renal cell carcinoma (RCC) is the sixth most common cancer in men and the eighth in women in the USA. In Italy RCC incidence was 11500 new cases in 2017, while mortality was 3371 cases in 2015. Increa...
Eligibility Criteria
Inclusion
- Histologically confirmed aRCC
- Metastatic disease (measurable and not-measurable)
- Radiological assessment within 8 wks before enrollment
- Patient eligible to therapy with ICI for aRCC (or started within 8 wks)
- Ability to provide written informed consent
- Ability to be compliant with the scheduled procedures
Exclusion
- Major comorbidities
- Concomitant GI or autoimmune disorders, or HIV, HBV, HCV infection
- Continuative corticosteroid therapy
- Previous treatment with systemic immune-suppressants or immune-modulatory drugs
- Antibiotic therapy within 4 weeks prior to enrollment
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04758507
Start Date
February 18 2021
End Date
July 28 2025
Last Update
September 8 2025
Active Locations (2)
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1
Digestive Disease Center
Rome, Rome, Italy, 00168
2
Gianluca Ianiro
Rome, Rome, Italy, 00168