Hepatoblastoma and liver cancer (hepatocarcinoma)
Conditions
Interventions
Trade Name: Cisplatinum Accord
Product Name: Cisplatinum
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Carboplatin Accord
Product Name: Carboplatin
Pharmaceutical Form: Conce
Sponsors
Medical University of Gdansk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinically signs of Hepatoblastoma or Hepatocarcinoma (malignant tumors of the liver) + liver tumor; Age under 30; Signing informed consent to participate in the Study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previously or currently receiving chemotherapy treatment; Recurrence of the disease; Condition after organ transplantation; Uncontrolled generalized infection; Inability to conduct the Study in accordance with the Protocol; Other Associated Cancer; Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. The possibility of individualizing the treatment of malignant liver tumors in children by classifying them into different groups according to the stage of the disease; 2. The possibility of reducing the occurrence of treatment side effects without significantly affecting the cure rate; 3. Improvement of curability, where current therapy is still not effective enough; 4. Selection of the most effective methods of surgical treatment;Secondary Objective: 1. Identification of biological features and genetic determinants of liver cancer; 2. Modification of the classification of liver tumors in children.;Primary end point(s): The study will remain open until the last visit of the last patient participating in the study. The Main Sponsor will notify the relevant authorities, including the Bioethics Committee, of this fact and provide a report on the conduct of the Study within 12 months of the end of the Study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study will remain open until the last visit of the last patient participating in the study. The Main Sponsor will notify the relevant authorities, including the Bioethics Committee, of this fact and provide a report on the conduct of the Study within 12 months of the end of the Study | — |
Countries
Poland
Contacts
Public ContactPiotr Widlak
Biuro „Centrum Wsparcia Badan Klinicznych Gdanskiego Uniwersytetu Medycznego"
Outcome results
None listed