Trial Condition(s):

Carcinoma, Hepatocellular

Sorafenib for residue disease after resection with curative intent (SECURE)

Bayer Identifier:

16621

ClinicalTrials.gov Identifier:

NCT01751763

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Radical hepatic resection represents one of the treatment options offering a prospect for cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of these “radical resection” actually turned out to be non-radical in nature. For these patients who actually received non-radical resection, their by year survival rates were much lower than those who received radical hepatectomy. In this prospective, non-interventional, multi-center study, we are planning to observe the patient characteristics of Hepatocellular carcinoma (HCC) patients who have residual disease after resection with curative intent, as well as treatment pattern, safety and effectiveness of sorafenib for these patients.

Inclusion Criteria
- Patients with histologically confirmed HCC and have residual disease after resection with curative intent and for whom a decision to treat with Sorafenib has been made. 
 The definitions of non-radical resection are as follows:
Liver tumor rupture or adjacent organ invasion, confirmed by intra-operative or post-operative pathology;
Positive resection margin, confirmed by post- operative pathology;
Lymph node metastasis confirmed by  intra-operative or post- operative pathology;
Residue lesion confirmed by post-operative digital subtraction angiography (DSA); 
Macroscopic/microscopic tumor thrombi of vein and/or bile duct, confirmed intraoperative / post-operative pathology;
Number of tumors >=3, confirmed by preoperative radiographic inspection (CT, MRI or BUS), intraoperative BUS, or post-operative pathology.
AFP alpha fetoprotein(AFP) remains higher than Upper Limits of Normal (according to local lab’s range), confirmed by local laboratory test at least 2 months after surgery.
 - Confirmation of complete response (no visible residual tumor), on the eligibility scan (CT or MRI) by local radiological review, performed >2 weeks after surgery; 
 - Patients must be followed up regularly after surgery (time interval and method based on physician’s daily practice), have no documented tumor recurrence by eligibility scan (CT or MRI) before Sorafenib treatment;
 - Patients must have physically/mentally recovered from surgery and considered to be able to tolerant Sorafenib therapy, by investigator’s judgment;
Exclusion Criteria
- The approved local product label must be followed for the exclusion criteria

Trial Summary

Enrollment Goal
106
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design