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A phase II study on adjuvant vaccination with dendritic cells loaded with autologous tumor homogenate in resected stage IV rare cancers: neuroendocrine tumors (NET) and soft tissue sarcoma (STS).

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510251-31-00
Acronym
IRST100.42
Enrollment
30
Registered
2024-07-17
Start date
2019-12-12
Completion date
Unknown
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroendocrine tumors, soft tissue sarcoma

Brief summary

Proportion of patients experiencing grade 3 or higher adverse events, Number of patients showing enhancement in the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease

Detailed description

Overall survival; relapse-free survival, Proportion of patients with positive DHT test will be calculated and the predictive role will be analyzed taking account of the relationship with the primary and the other secondary outcomes, All the immunological objectives will be calculated in terms of proportion and the correlation with efficacy and safety parameters will be explored

Interventions

Sponsors

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients experiencing grade 3 or higher adverse events, Number of patients showing enhancement in the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease

Secondary

MeasureTime frame
Overall survival; relapse-free survival, Proportion of patients with positive DHT test will be calculated and the predictive role will be analyzed taking account of the relationship with the primary and the other secondary outcomes, All the immunological objectives will be calculated in terms of proportion and the correlation with efficacy and safety parameters will be explored

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026