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Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Hepatoma

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Trial Information

Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma

Inclusion Criteria:

1. Unresectable hepatocellular carcinoma patients with liver-predominant disease as
described in section 5.1, or patients with hepatocellular carcinoma who refuse
surgery. No more than 30% of the cohort should have macrovascular invasion and/or
asymptomatic extrahepatic disease. Multifocal HCC is acceptable, no diffuse HCC.

2. Age > 18 years old

3. ECOG performance status of 0-1

4. Childs class of A or B (up to 7) (see Table 5.0)

5. Adequate end-organ function as manifested by:

- Absolute neutrophil count of > 1500/mm3 and platelets > 50,000/mm3

- Creatinine ≤ 2.0

- AST ALT < 5 x ULN

- Total bilirubin of ≤ 3

- Albumin > 2.0

- INR < 2.0

- Leukocyte count >3000 cells/mm3

6. Amylase and lipase ≤ 1.5 the upper limit of normal

7. Patients who have received previous hepatic surgery , RFA, PEI, or cryoablation are
eligible if target lesion(s) have not been treated and local therapy completed > 6
weeks prior to entry.

8. Left ventricular ejection fraction ≥ 45%

9. Patients with asymptomatic HIV infection are not eligible

10. Willingness of male and female subjects, who are not surgically sterile or post
menopausal, to use reliable methods of birth control for the duration of the study
and for 30 days after the last dose of study medication.

11. Patient must have signed informed consent prior to registration on study.

12. Resolution of all acute toxic effects of any prior local treatment to CTC adverse
event Grade 1 or 0.

13. At least one tumor lesion can be accurately measured in at least one dimension
according to RECIST. The lesion has not been previously treated with local therapy
(such as surgery, radiation therapy, RFA, PEI, or cryoablation) unless it has shown
progression in the interim.

Exclusion Criteria:

1. Patients unable to swallow oral medications

2. Prior embolization, systemic or radiation therapy for HCC (liver)

3. Tumor burden in the liver exceeding 70%.

4. Complete occlusion of the entire portal venous system

5. Ascites refractory to diuretic therapy (minimal or trace on imaging is acceptable)

6. Previous or concurrent cancer that is distinct in primary site or histology from HCC,
except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
tumors (Ta, Tis, and T1). Any cancer curatively treated > 3 years prior is

7. Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry

8. History of bleeding within the past 4 weeks (unless deemed by PI as clinically
insignificant, for ex., a brief episode of epistaxis)

9. Any contraindication to doxorubicin administration

10. Evidence of severe or uncontrolled systemic diseases,

11. Congestive cardiac failure >NYHA class 2, MI within 6 months, active coronary artery
disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta
blockers or digoxin, unstable angina, or laboratory finding that in the view of the
investigator makes it undesirable for the patient to participate in the trial

12. Any prior history of hypertensive crisis or hypertensive encephalopathy

13. History of stroke or transient ischemic attack within 6 months prior to study

14. Inadequately controlled hypertension (defined as systolic blood pressure of 150/100
mmHg on antihypertensive medications) (patients with treated hypertension are

15. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, peripheral
vascular disease)

16. History of organ allograft

17. Presence of grade > 2 hepatic encephalopathy (see Appendix D)

18. Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an additional experimental drug

19. Evidence of bleeding diathesis or coagulopathy or on warfarin. Note: If a patient
has been on coumadin for a period of 1 month and has been stable, they may be
accepted into the protocol.

20. Presence of clinically evident central nervous system or brain metastases

21. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1, anticipation of need for major surgical procedure during the course
of the study

22. Vascular anatomy that precludes catheter placement or injection of LC Bead

23. Presence of collateral vessel pathways potentially endangering normal territories
during embolization

24. Pregnant (positive pregnancy test) or lactating

25. Inability to comply with study and/or follow-up procedures

26. Life expectancy of less than 12 weeks

27. Child B8, B9 and C

28. ECOG ≥ 2

29. Patients with concomitant HIV infection or AIDS-related or serious acute or chronic

30. Presence of porto-systemic shunt

31. Severe atheromatosis

32. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of study results

33. Active clinically serious infections (>grade 2)

34. Patients receiving therapy for hepatitis A, B, or C.

35. Patients with obvious and/or symptomatic extrahepatic disease. Findings of uncertain
significance, such as lung lesions less than 10 mm in diameter or enlarged periportal
lymph nodes will not exclude patients, however, findings highly suspicious for
metastatic HCC will exclude patients from this study.

36. Any contraindication for an arterial procedure such as impaired clotting tests
(platelet count < 50.000/mm3 or prothrombin activity < 50 percent)

37. Any contraindication for systemic chemotherapy administration (serum bilirubin >
3mg/dL, leukocyte count < 3.000 cells/mm3)

38. Any contraindication for sorafenib administration

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be assessed by grading toxicities reported at intervals throughout the study. Higher grade toxicities will be assessed for their degree of relatedness to the study treatment.

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatoma
  • primary liver cancer
  • sorafenib
  • Nexavar
  • doxorubicin
  • drug eluting beads
  • transarterial chemoembolization
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



The Johns Hopkins Hospital Baltimore, Maryland  21205