A clinical trial in children and adolescents with primary malignant liver cancer - Hepatoblastoma and Hepatocarcinoma.
Phase 1
- Conditions
- Hepatoblastoma and liver cancer (hepatocarcinoma)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2023-000036-30-PL
- Lead Sponsor
- Medical University of Gdansk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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