BridgeMD
Paediatric Hepatic International Tumour Trial
EU CTIS ID: 2024-516110-38-00
What this study is testing
Group A - Very Low-Risk HB Patients, depending on their tumour histology, will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies. Group B - Low-Risk HB In patients who are resected after 2 courses (Group B1), the aim is to evaluate whether the outcome with a total of 4 cycles of treatment is not inferior to those receiving a total of 6 cycles of treatment. Patients who are not resected after 2 courses (Group B2) will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies. Group C - Intermediate Risk HB To compare outcome and toxicity in patients treated with: (i) cisplatin/5-fluorouracil/vincristine/doxorubicin (C5VD); (ii) SIOPEL-3 high-risk chemotherapy with cisplatin, carboplatin and doxorubicin (SIOPEL-3HR); (iii) dose compressed cisplatin monotherapy (CDDP-M). Group D - High-Risk HB In patients who have cleared metastatic disease with induction chemotherapy, treatment is standard as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies. In patients who have not cleared metastatic disease with induction chemotherapy +/- surgery, the aim is to compare the outcomes of the following post-induction treatments: (i) carboplatin and doxorubicin (CD) alternating with carboplatin and etoposide (CE); (ii) carboplatin and doxorubicin (CD) alternating with vincristine and irinotecan (VI). Group E - Resected HCC Patients will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies. Group F - Unresected HCC: Patients with microscopic residual disease after resection will be included in this group. The aim is to determine whether the addition of gemcitabine, oxaliplatin and sorafenib (GEMOX + sorafenib) to cisplatin, doxorubicin and sorafenib (PLADO+Sorafenib), in a dose compressed fashion improves outcome.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- General criteria • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: a) The patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy. b) There is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.). c) Uncorrectable coagulopathy.
- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- General criteria • Age ≤30 years
- Group D • Patient meets High Risk definition according to CHIC Guidelines
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
You likely can't join if
- • Any previous chemotherapy or currently receiving anti-cancer agents
- • Concomitant use with St John’s Wort which cannot be stopped prior to start of trial treatment
- Group F: • Peripheral Sensitive Neuropathy with functional impairment
- • Personal or family history of congenital long QT syndrome
- • QT/QTc interval >450msec for men and >470msec for women (corrected measurement of QT according to BAZETT formula)
- • Patients who are unable to swallow tablets , where an oral solution is not available or approved
See the full eligibility criteria
- General criteria • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: a) The patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy. b) There is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.). c) Uncorrectable coagulopathy.
- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- General criteria • Age ≤30 years
- Group D • Patient meets High Risk definition according to CHIC Guidelines
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- Group E - At diagnosis: • Patient has been diagnosed with HCC
- • Tumour has been resected with negative margins Group E1
- • HCC secondary to underlying liver disease
- Group A2 - Treatment arm • Central pathology review confirming non-WDF histology.
- Group E2 • HCC de novo, including fibrolamellar
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
- General criteria • Written informed consent for trial entry
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- Group F • Patient diagnosed with HCC
- • Tumour locally assessed as un-resectable, or metastatic HCC disease
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age o Qt/QTc interval =/<450msec for males, =/<470msec for females
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- For Allocation/Randomisation to Treatment Group: All Groups • Written Informed Consent for trial treatment participation
- For Allocation/Randomisation to Treatment Group: All Groups • Patient assessed as fit to receive group specific treatment
- For Allocation/Randomisation to Treatment Group: All Groups • For females of child-bearing potential, a negative pregnancy test prior to trial entry is required. Any patient who is of reproductive age must agree to use adequate contraception for the duration of the trial.
- Group A (no treatment arm) - At diagnosis: • Resected Tumour.
- Group A1 – No treatment arm • Patient meets Very Low Risk definition according to CHIC guidelines.
- Group A1 – No treatment arm • Central pathology review confirming WDF histology.
- Groups B, C & D - Real time review required if age>8 and/or AFP<100 – confirm HB diagnosis
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- Group B • Patient meets Low Risk definition according to CHIC Guidelines
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
- Group C • Patient meets Intermediate Risk definition according to CHIC Guidelines
- • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
- • Any previous chemotherapy or currently receiving anti-cancer agents
- • Concomitant use with St John’s Wort which cannot be stopped prior to start of trial treatment
- Group F: • Peripheral Sensitive Neuropathy with functional impairment
- • Personal or family history of congenital long QT syndrome
- • QT/QTc interval >450msec for men and >470msec for women (corrected measurement of QT according to BAZETT formula)
- • Patients who are unable to swallow tablets , where an oral solution is not available or approved
- • Recurrent disease
- • Previously received a solid organ transplant
- • Uncontrolled infection
- • Unable to follow the protocol for any reason
- • Second malignancy
- • Pregnant or breastfeeding women
- Treatment Group Specific Exclusion Criteria Group C: • Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Group D: • Chronic inflammatory bowel disease and/or bowel obstruction
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United Kingdom
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United Kingdom; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.