EUCTR2017-002517-64-GB进行中（未招募）1 期
An open label, single-arm, Phase I/II study of vandetanib-eluting radiopaque embolic beads (BTG-002814) in patients with hepatocellular carcinoma (HCC) without curative options - VALENCIA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •1. Male or female adults (=18 years old)
- •2. Primary confirmed diagnosis of HCC according to the EASL criteria or histology
- •3. Patient is a candidate for TACE and is not eligible or amenable for curative treatment (resection, liver transplantation or percutaneous ablation)
- •4. Part A: Patients with unilobar tumours. Patient must have a single tumour diameter of 5 cm or more or multiple tumours with the sum of the diameters being 8 cm or more
- •Part B: Patients with unilobar or bilobar tumours. For bilobar tumours, both lobes must be able to be treated in the same session
- •5. Measurable disease according to mRECIST and RECIST 1.1
- •6. Performance Status ECOG 0 or 1
- •7. Part A: Patients with well preserved liver function (Child-Pugh A with no clinically detectable ascites, or if minor ascites on imaging, the patients must have no diuretic medication).
- •Part B: Patients with Child-Pugh A or B7
- •8. Adequate haematological function with Hb >90 g/L, absolute neutrophil count (ANC) >1.5 x 109/L, Plt >75 x 109/L, INR =1.5
- •9. Adequate liver function with serum bilirubin <1.5 x ULN, ALT (or AST if ALT not available) =5 x ULN, ALP <5 x ULN, serum albumin >28 g/L
- •10. Adequate renal function with serum creatinine =1.5 x ULN and calculated creatinine clearance (GFR ) =50 mL/min estimated using a validated creatinine clearance calculation (e.g. Cockroft-Gault or Wright formula).
- •11. Patient is able and willing to participate in the study and has provided written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Advanced tumoural disease, vascular invasion (VP3, VP4) of the tumour extrahepatic spread
- •2. Patients previously treated in the same liver lobe with transarterial embolisation (with or without chemotherapy) of the liver, prior radiotherapy or prior yttrium-90 microsphere therapy
- •3. Patients who are currently on the liver transplant waiting list
- •4. Part A: Patients with bilobar disease
- •5. Part A: Advanced liver disease patients who are Child-Pugh >A6 or who have active gastrointestinal bleeding
- •Part B: Advanced liver disease patients who are Child-Pugh >B7 or who have active gastrointestinal bleeding
- •6. Any contraindication to vandetanib according to its label including:
- •a.Hypersensitivity to the active substance
- •b. Congenital long QTc syndrome.
- •c. Patients known to have a QTc interval over 480 milliseconds.
- •d. Concomitant use of medicinal products also known to also prolong the QTc interval and/or induce Torsades de pointes (See Appendix 1)
- •7. Any contraindication to hepatic artery catheterisation or hepatic embolisation procedures (e.g. portal venous thrombosis, severely reduced portal venous flow or hepatofugal blood flow, untreated varices at high risk of bleeding) biliary obstruction, bilio-enteric anastomosis and incompetent ampulla of vater
- •8. Women of childbearing potential not using effective contraceptive methods or women who are breast feeding
- •9. Confirmed allergy to iodine-based intravenous contrast media that cannot be managed with standard of care
- •10. Any co-morbid disease or condition or event that, in the Investigator’s judgment, would place the patient at undue risk, that and would preclude the safe use of treatment with BTG-002814
- •11. Patients who cannot have Computerized Tomography (CT) imaging (according to site policy)
- •12. Levels of potassium, calcium, magnesium or Thyroid Stimulating Hormone (TSH) outside the normal ranges, and that in the Investigator’s judgement are clinically significant, or laboratory findings that in the view of the Investigator makes it undesirable for the patient to participate in the study
- •13. History of second malignancy (except those treated with curative intent for more than three years previously without relapse) and non-melanoma skin cancer or cervical carcinoma in situ
- •14. Patients who have received treatment in another clinical study with an investigational product within 4 weeks prior to the screening visit.
- •15. Concomitant treatment with any other anti cancer treatment (chemotherapy, targeted therapy, immunotherapy, Chinese medicine)
- •16. Patients previously treated with any systemic anti-cancer therapy for HCC
研究者
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