EUCTR2016-002828-85-BE进行中（未招募）1 期
Paediatric Hepatic International Tumour Trial - PHITT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For Trial Entry:
- •Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC.
- •Age =30 years
- •Written informed consent for trial entry
- •For Allocation/Randomisation to Treatment Group:
- •Written Informed Consent for trial treatment participation
- •Patient assessed as fit to receive group specific treatment
- •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.
- •Patient meets Very Low Risk definition according to CHIC guidelines.
- •Group A1 – No treatment arm
- •Central pathology review confirming WDF histology.
- •Group A2- Treatment arm
- •Central pathology review confirming non-WDF histology.
- •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:
- •o Absolute neutrophil count (ANC) >0.75 x 109/L
- •o Platelet count >75 x 109/L
- •o Prothrombin time (PT) <1.2x ULN for age-based local reference values
- •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:
- •o Absolute neutrophil count (ANC) >0.75 x 109/L
- •o Platelet count >75 x 109/L
- •o Prothrombin time (PT) <1.2x ULN for age-based local reference values
- •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
- •Adequate cardiac function determined by:
- •o Shortening fraction =28% by local assessment method
- •o OR Ejection fraction =47% by local assessment method
- •Adequate haematology:
- •o Absolute neutrophil count (ANC) >0.75 x 109/L
- •o Platelet count >75 x 109/L
- •o Prothrombin time (PT) <1.2x ULN for age-based local reference values
- •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:
- •o Absolute neutrophil count (ANC) >0.75 x 109/L
- •o Platelet count >75 x 109/L
- •o Prothrombin time (PT) <1.2x ULN for age-based local reference values
- •Patient has been diagnosed with HCC
- 另有 10 项未显示
排除标准
- •Any previous chemotherapy or currently receiving anti-cancer agents
- •Recurrent disease
- •Previously received a solid organ transplant
- •Uncontrolled infection
- •Unable to follow the protocol for any reason
- •Second malignancy
- •Pregnant or breastfeeding women
研究者
相似试验
进行中（未招募）
1 期
Paediatric Hepatic International Tumour TrialHepatoblastoma and Hepatocellular Carcinoma.MedDRA version: 20.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10062001Term: HepatoblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002828-85-FRniversity of Birmingham300
进行中（未招募）
1 期
Paediatric Hepatic International Tumour TrialHepatoblastoma and Hepatocellular Carcinoma.MedDRA version: 20.0 Level: PT Classification code 10062001 Term: Hepatoblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002828-85-ATniversity of Birmingham300
进行中（未招募）
1 期
Paediatric Hepatic International Tumour TrialEUCTR2016-002828-85-DEniversity of Birmingham300
进行中（未招募）
1 期
Paediatric Hepatic International Tumour TrialHepatoblastoma and Hepatocellular Carcinoma.MedDRA version: 20.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000143675MedDRA version: 20.0Level: PTClassification code 10062001Term: HepatoblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 100000143675EUCTR2016-002828-85-ESniversity of Birmingham1,140
招募中
3 期
Paediatric Hepatic International Tumour TriallivercancerLivertumor10019815NL-OMON50638niversity of Birmingham25