Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA (Primovist) enhanced MRI in patients with inoperable liver cancer (SORAMIC)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 710

Inclusion Criteria

1. Age: 18-85 years
2. Hepatocellular carcinoma
3. If extrahepatic metastases: liver-dominant disease
4. Stage BCLC A, B, or C
5. Child-Pugh A, Child-Pugh B up to 7 points
6. Willing to comply with all study procedures
7. Has voluntarily given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 443

Exclusion Criteria

1. If female, pregnant or breast feeding (females of child-bearing
potential must use adequate contraception and must have a negative
pregnancy test performed within 7 days prior to inclusion into this
study)
2. If male, not using adequate birth control measures
3. One or more of the following:
- Hemoglobin <10g/dL,
- WBC <2,500 cells/mm3,
- ANC <1,500 cells/mm3,
- platelets <50,000/mm3,
- ECOG performance status >2
4. Life expectancy <16 weeks or medically unstable
5. Pulmonary metastases
6. Patients with known GFR <30 mL/min/1.73m2
7. PT-INR/PTT >1.5 times the upper limit of normal
8. uncontrolled infections at the time of microtherapy
9. Child-Pugh score >7 points;
10. Uncontrolled ascites
11. tumor load of the whole liver >70%
12. Contraindications for study medications according to product
labeling or procedures
13. Having undergone surgical procedures with resection of the
sphincter of Oddi
14. Significant cardiovascular disease; e.g., myocardial infarction within
6 months of inclusion, chronic heart failure (New York Heart Association
class III or IV), unstable coronary artery disease
15. Uncontrolled hypertension
16. Thrombotic or embolic events including transient ischemic attacks
within the past 6 months (tumor-related portal vein thrombosis allowed
in the palliative part of the trial)
17. History of GI bleeding within 30 days before inclusion into this
study
18. History of esophageal varices bleeding which has not been
controlled by effective therapy and/or therapy to prevent bleeding
recurrence
19. Previous malignancy other than carcinoma in situ of the skin or the
cervix uteri within 5 years prior to inclusion
20. History of organ transplant (including prior liver transplantation)
21. HIV, congenital immune defect, any immunosuppressive therapy for
autoimmune disease (rheumatoid arthritis) or inflammatory bowel disease
22. Mental conditions rendering the subject incapable to understand
the nature, scope, and consequences of the trial
23. Close affiliation with the investigational site; e.g. first-degree
relative of the investigator.
24. Participating in another therapeutic clinical trial or has completed
study participation in another therapeutic clinical trial within 30 days of
enrolment into this trial
25. Having been previously enrolled in this clinical trial

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

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