NL-OMON50638招募中3 期
Paediatric Hepatic International Tumour Trial - PHITT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
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 entryFor 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
- •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
- •Adequate hematology / biochemistryGroup B
- •Patient meets Low Risk definition according to CHIC Guidelines
- •Adequate renal function
- •Adequate hematology / biochemistryGroup C
- •Patient meets Intermediate Risk definition according to CHIC Guidelines
- •Adequate renal function
- •Adequate cardiac function
- •Adequate hematology / biochemistry
- •Patient meets High Risk definition according to CHIC Guidelines
- •Adequate renal function
- •Adequate cardiac function
- •Adequate hematology / biochemistry
- •Patient has been diagnosed with HCC
- •Tumour has been locally assessed as resectable
- •Adequate renal function
- •Adequate cardiac function
- •Adequate hematology / biochemistryGroup F
- •Patient diagnosed with HCC
- •Tumour locally assessed as un-resectable, or metastatic HCC disease
- •Adequate renal function
- •Adequate cardiac function
- •Adequate hematology / biochemistrySee protocol paragraph 4 for the
- •definitions of adequate organ function
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 womenGroup specific exclusion criteria
- •All Groups:
- •-Hypersensitivity to any medicines used in allocated group. Group C:
- •-Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
- •-Chronic inflammatory bowel disease and/or bowel obstruction
- •-Concomitant use with St John*s Wort which cannot be stopped prior to start of
- •trial treatment Group F:
- •-Low K, Mg or Ca which remains uncorrected by electrolyte supplementation
- •-Peripheral Sensory Neuropathy with functional impairment
- •-Personal or family history of congenital long QT syndrome
- •-QT/QTc interval >450msec for males and >470msec for females
- •-Patients who are unable to swallow tablets where an oral suspension is not
- •available or not approved
- •e Laag Risic
研究者
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