patients affected by colangiocarcinoma or hepatic metastasis for colon-rectal cancer MedDRA version: 9.1 Level: SOC Classification code 10017947
Conditions
Interventions
Trade Name: MYELOSTIM 34
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Lenograstim
Concentration unit: million IU million international units
Concentration ty
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients aged between 18 and 75 years old; patients affected by colangiocarcinoma or hepatic metastasis for colon-rectal cancer with indication to undergo PVE o PVL procedures to increase FRLV for future resection radical surgery of the disease. 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: clinical evidence for cirrosis;splenomegaly; specific counter-indication for the drug;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to increase the percentage of patients undergoing resective healing surgery;Secondary Objective: increase of epatic hypertropy; improvement of postsurgery outcome;Primary end point(s): drop out reduction of patients undergoing surgery | — |
Countries
Italy
Outcome results
None listed