EUCTR2007-004795-39-IT进行中（未招募）不适用
A PHASE 3 RANDOMIZED STUDY TO EVALUATE SURVIVAL OF PATIENTS TREATED WITH TALAPORFIN SODIUM (LS11) AND INTERSTITIAL LIGHT EMITTING DIODES (LED) AS COMPARED TO THE STANDARD OF CARE THERAPIES IN THE TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) - ND
IGHT SCIENCES ONCOLOGY0 个研究点目标入组 200 人开始时间: 2008年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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. A diagnosis of primary Hepatocellular Carcinoma (HCC),
- •established by any one of the following criteria in a clinical setting
- •suggestive of HCC:
- •A. Two different imaging techniques with characteristics that
- •suggest HCC
- •B. Combination of one imaging technique that suggests HCC and
- •serum AFP level >400 ng/mL
- •C. Histological evidence of HCC
- •2. Patients who are candidates for surgery with curative intent are not
- •3. Patients with 6 or more lesions are not eligible
- •4. Patients with greater than 50% of parenchyma disease involvement
- •are excluded
- •5. Patients with Child-Pugh C cirrhosis are excluded
- •6. Patients with diffuse HCC are excluded
- •7. Patients with grade 3 ascites are excluded
- •8. Evidence of major vessel invasion or extrahepatic disease is
- •excluded. Lymph node involvement in the hilum region of the liver
- •is eligible if the nodes do not exceed 2 cm.
- •9. ECOG Performance Status 0-2
- •10. Life expectancy of at least 16 weeks
- •11. Patients may have received previous antineoplastic therapy; at least 3
- •weeks must have elapsed since the completion of any prior therapy
- •and the patient must have recovered from acute side effects.
- •12. Known sensitivity to porphyrin-type drugs or known history of
- •porphyria are exclusionary
- •13. Understanding and ability to sign written informed consent
- •14. 18 years of age or more
- •15. Pregnancy or breast-feeding patients are excluded. A negative
- •pregnancy test (urine or serum) from women of childbearing age is
- •required prior to enrollment. A fertile patient must use effective
- •contraception during participation in the study
- •16. Adequate hematologic, liver and renal functions as evidenced by the
- •WBC > 2,400/mm3
- •Platelet Count > 75,000/μl
- •Hemoglobin > 9.4 gm/dL
- •PT and PTT < 1.5 Control
- •SGOT, SGPT < 5 x ULN
- •Bilirubin < 2.5 x ULN
- •Alk Phos < 3 x ULN
- •Creatinine < 2.5 mg/dL (SI: 221 μmol/L)
- •Albumin > 2 g/dL
- •17. Concurrent participation in another clinical trial involving
- •experimental treatment is excluded
- •18. Any concurrent disease or condition that in the opinion of the
- •investigator impairs the patient?s ability to complete the trial such as
- •psychological, familial, sociological, geographical or medical
- •conditions which in the Principal Investigator?s opinion could
- •compromise compliance with the objectives and procedures of this
- •protocol or obscure interpretation of the trial?s data are excluded.
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •17. Concurrent participation in another clinical trial involving
- •experimental treatment is excluded18. Any concurrent disease or condition that in the opinion of the
- •investigator impairs the patient?s ability to complete the trial such as
- •psychological, familial, sociological, geographical or medical
- •conditions which in the Principal Investigator?s opinion could
- •compromise compliance with the objectives and procedures of this
- •protocol or obscure interpretation of the trial?s data are excluded.
研究者
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