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Modulation of the immune response in patients with pancreatic tubular carcinoma - MIS-MIT

Modulation of the immune response in patients with pancreatic tubular carcinoma - MIS-MIT

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006710-23-SI
Enrollment
30
Registered
2009-10-02
Start date
2009-10-02
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Pancreatic adenocarcinoma

Interventions

Product Name: Pripravek MNC za zdravljenje Product Code: MIS_MIT Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the pla

Sponsors

Blood Transfusion Centre of Slovenia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ECOG performace status 0, 1 or 2 at the time of randomization, 2. following R0 or R1 pancreatic tubular adenocarcinoma (larger than 2 centimeters) resection, 3. completed adjuvant gemcitabine chemotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. expected survival of less than three months, 2. R2 resection, 3. metastatic disease (M1 or N1).

Design outcomes

Primary

MeasureTime frame
Main Objective: Time to disease progression.;Secondary Objective: Quality of life. Overall survival.;Primary end point(s): Significant time to disease progression difference between experimental and placebo group.

Countries

Slovenia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026