Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
NCT02919644 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2024-09-19
Summary
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
- Stage IV Colorectal Cancer
- Curative Resection
Interventions
- BIOLOGICAL
-
autologous dendritic cells loaded with autologous tumour homogenate
Each vaccine dose consists of 10\_7 autologous dendritic cells loaded with autologous tumor homogenate
- DRUG
-
IL2
Each vaccine dose is followed, after two days, by IL-2 as adjuvant, at a dose of 3 MU daily for five consecutive days
Sponsors & Collaborators
-
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
lead OTHER
Principal Investigators
-
Francesco De Rosa, MD · UO Immunoterapia e Laboratorio TCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-02
- Primary Completion
- 2026-12-31
- Completion
- 2031-12-31
Countries
- Italy
Study Locations
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