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
- Conditions
- Hepatocellular carcinomaMedDRA version: 9.1Level: PTClassification code 10019695Term: Hepatic neoplasm
- Registration Number
- EUCTR2007-004795-39-IT
- Lead Sponsor
- IGHT SCIENCES ONCOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
eligible
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
following:
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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method