Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
14
Hepatoblastoma and liver cancer (hepatocarcinoma)
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, …
Key facts
- Sponsor
- Medical University Of Gdansk
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Aug 2025 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Medical Research Agency (Agencja Badań Medycznych)
External identifiers
- EU CT number
- 2024-514635-26-00
- EudraCT number
- 2023-000036-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacogenetic, Diagnosis, Efficacy
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 objectives 1
- 1. Identification of biological features and genetic determinants of liver cancer; 2. Modification of the classification of liver tumors in children.
Conditions and MedDRA coding
Hepatoblastoma and liver cancer (hepatocarcinoma)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Clinically signs of Hepatoblastoma or Hepatocarcinoma (malignant tumors of the liver) + liver tumor; Age under 30; Signing informed consent to participate in the Study
Exclusion criteria 1
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Depend on the Study Group: event-free survival, overall survival, adherence to surgical guidelines, chemotherapy-related toxicity, hearing loss, response, failure-free survival, surgical resectability.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1137788 · ATC
- Active substance
- Vinorelbine
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 36 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139021 · ATC
- Active substance
- Irinotecan Hydrochloride
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 10000 mg milligram(s)
- Max treatment duration
- 140 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP138158 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11481719 · Product
- Active substance
- Sodium Thiosulfate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25.6 g gram(s)
- Max total dose
- 204.8 g gram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MEDICAL UNIVERSITY OF GDANSK
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- 00000
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP45063462 · ATC
- Active substance
- Sorafenib Tosilate
- Substance synonyms
- Sorafenib tosylate
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 40000 mg milligram(s)
- Max treatment duration
- 100 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XE05 — SORAFENIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1128788 · ATC
- Active substance
- Gemcitabine Hydrochloride
- Substance synonyms
- 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 8000 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Gdansk
- Sponsor organisation
- Medical University Of Gdansk
- Address
- Ul. Marii Sklodowskiej-Curie 3a
- City
- Gdansk
- Postcode
- 80-210
- Country
- Poland
Scientific contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Chief Medical Officer; Principal Investigator
Public contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Director of Clinical Research Support Centre
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 60 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Klinika Onkologii Hematologii i Transplantologii Pediatrycznej, Szpitalna 27/33, 60-572, Poznań
Uniwersytecki Szpital Klinicznym Nr 1 Pomorskiego Uniwersytetu Medycznego
Klinika Pediatrii, Onkologii i Immunologii Dziecięcej, Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Dziecięcy w Krakowie
Klinika Onkologii i Hematologii Dziecięcej, Wielicka 265, 30-663, Kraków
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Klinika Pediatrii, Onkologii i Hematologii, ul. Sporna 36/50, 91-738, Łódź
Medical University Of Gdansk
Klinika Chirurgii i Urologii Dzieci i Młodzieży Gdańskiego Uniwersytetu Medycznego, Ul. Marii Sklodowskiej-Curie 3a, 80-210, Gdansk
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej, Borowska 213, 50-556, Wrocław
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Hematologii i Onkologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze
Górnośląskie Centrum Zdrowia Dziecka
Oddział Onkologii, Hematologii i Chemioterapii, Medyków 16, 40-752, Katowice
Uniwersytecki Szpital Dziecięcy w Lublinie
Klinika Hematologii, Onkologii i Transplantologii Dziecięcej, ul. Profesora Antoniego Gębali 6, 20-093, Lublin
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie
Klinika Onkohematologii Dziecięcej, Lwowska 60, 35-301, Rzeszów
Instytut Pomnik Centrum Zdrowia Dziecka
Klinika Onkologii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy
Klinika Pediatrii, Hematologii i Onkologii, ul. Marii Skłodowskiej-Curie 9, 85-095, Bydgoszcz
Uniwersytecki Dziecięcy Szpital Kliniczny im. Ludwika Zamenhofa w Białymstoku
Klinika Pediatrii, Onkologii i Hematologii, ul. Jerzego Waszyngtona 17, 15-274, Białystok
Uniwersyteckie Centrum Kliniczne w Gdańsku
Klinika Pediatrii, Hematologii i Onkologii, ul. Smoluchowskiego 17, 80-952, Gdańsk
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-08-28 | 2025-10-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 43 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protoko Polphitt clean version wersja 1_1 data 11_09_2023 | 2.0 |
| Protocol (for publication) | Protoko PolSTS clean wersja 1_1 data 11_09_2023 | 2.0 |
| Recruitment arrangements (for publication) | Placeholder_advanced_13-08-2024_General | 1.0 |
| Subject information and informed consent form (for publication) | 23_07_17_Ogolna informacja o badaniu dla pacjenta 8_12 lat clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent 13__A2 clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent 13_B clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent 13_D clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent 13_E2 clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent 13_F clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_pacjent__C clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_rodzic_A2 clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_rodzic_B clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_rodzic_D clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_17_POLPHITT_rodzic_F clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Formularz przetwarzania danych osobowych POLPHITT _uczestnik clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Formularz przetwarzania danych osobowych POLPHITT_rodzic clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Formularz przetwarzania danych osobowych POLSTS rodzic clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Formularz przetwarzania danych osobowych POLSTS uczestnik clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Ogolna informacja o badaniu_pacjent_clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_POLPHITT_leczenie_patient_13_clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_POLPHITT_leczenie_rodzic clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_POLPHITT_rodzic_wstep clean | 1 |
| Subject information and informed consent form (for publication) | 23_07_20_POLPHITT_Wstep do badania pacjent_clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Wzor formularza swiadomej zgody pacjent POLSTS 13_17 clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Wzor formularza swiadomej zgody rodzic_POLSTS clean | 1 |
| Subject information and informed consent form (for publication) | 23_07_20_Wzor informacja_dla_Rodzica POLSTS_002_clean | 2.0 |
| Subject information and informed consent form (for publication) | 23_07_20_Wzor informacji dla pacjenta POLSTS clean | 2.0 |
| Subject information and informed consent form (for publication) | POLPHITT_rodzic_C clean | 2.0 |
| Subject information and informed consent form (for publication) | POLPHITT_rodzic_E2_clean | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 5-fu | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | cisplatyna | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | doksorubicyna | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | etopozyd | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Etopozyd Charakterystyka-32941-2024-01-12-17431_B-2024-04-09 updated | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | gemcytabina | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Irinotecan Charakterystyka-34153-2023-10-31-15719_B-2023-11-09 updated | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | irynotekan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | karboplatyna | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | oksaliplatyna | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | sorafenib | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | winkrystyna | 2.0 |
| Synopsis of the protocol (for publication) | Streszczenie protokou Polphitt clean version | 1.1 |
| Synopsis of the protocol (for publication) | Streszczenie protokou PolSTS clean version | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | Poland | Acceptable 2024-11-03
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-28 | Poland | Acceptable 2025-04-25
|
2025-06-05 |