Actively Recruiting
Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2024-09-19
19
Participants Needed
2
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer
CONDITIONS
Official Title
Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV colorectal cancer surgically treated with radical intent
- Autologous surgical specimen collected and meeting manufacturing standards
- Disease-free status confirmed by CT or MRI scans within 60 days before enrollment
- Recovery from surgery-related adverse events to grade 1 or less
- Age over 18 years
- ECOG performance status of 0 or 1
- Acceptable organ function with specified blood counts and liver/kidney levels
- For patients aged 70 or older, left ventricular ejection fraction at least 55% by echocardiography
- Commitment to effective contraception for patients of childbearing potential and their partners
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Presence of residual disease after surgery (except marginal resection without evident disease)
- Relapse within 6 months after primary treatment of stage I-III colorectal cancer
- Surgery completed more than 60 days before study enrollment
- History of other cancers in past 5 years except certain skin and cervical cancers
- History of congenital or acquired immunodeficiency or organ transplantation
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis within 30 days before manufacturing procedures
- Pregnancy or nursing in female patients
- Recent surgery after preoperative chemotherapy unless unable or unwilling to complete treatment
- Participation in another investigational trial within 30 days prior to screening
- Active inflammatory or autoimmune disease requiring systemic steroids or immunomodulators
- Contraindications to leukapheresis or low-dose IL-2 administration
- Uncontrolled serious illnesses or psychiatric/social conditions affecting safety or compliance
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UO Immunoterapia e Laboratorio TCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
Meldola, FC, Italy, 47014
Actively Recruiting
2
CRO-IRCCS Aviano
Aviano, Italy
Not Yet Recruiting
Research Team
O
Oriana Nanni, PhD
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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