A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2017-06-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

1. Written Informed Consent

2. ≥18 years of age

3. Diagnosis of HCC

4. Locally advanced HCC

5. Preserved liver function

6. Eastern Cooperative Oncology Group 0 or 1

Exclusion Criteria:

1. Presence of extra-hepatic spread of disease.

2. Macrovascular invasion of lobar portal vein branches or main portal vein.

3. Candidate for surgical resection, transplantation, or local ablation.

4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.

5. Any contraindication for TACE.

6. Platelet count <50,000/mm3 or international normalized ratio >1.5.

7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.

8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).

9. Known ejection fraction < 50%.

10. Current infections requiring antibiotic therapy.

11. Suffering from a known bleeding disorder.

12. Renal insufficiency (serum creatinine > 2 mg/dL).

13. Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.

14. Presence of advanced liver disease.

15. Any contraindication for doxorubicin administration:

16. Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.

17. Patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease

18. Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.

19. Pregnant or breast-feeding patients.