Study Completed

Carcinoma, Hepatocellular

Bayer Identifier:

16621

ClinicalTrials.gov Identifier:

NCT01751763

EudraCT Number:

Not Available

EU CT Number:

Not Available

Sorafenib for residue disease after resection with curative intent

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

July 2013 - September 2017

Phase

Phase 4

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, China

Primary Outcome

Patient characteristics: demographic, baseline characteristic, HCC diagnosis, prior HCC treatment, tumor status at operation, hepatic resection, time interval between surgery and Sorafenib, postoperative anti HCC treatment if any, past medical history
Time Frame:
up to 1 year
Safety Issue:
No
Treatment pattern of Sorafenib: duration and doses of Sorafenib, dose modification/discontinuation of Sorafenib, concomitant anti-cancer therapy, treatment after observed radiological recurrence.
Time Frame:
up to 3 years
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
Time Frame:
up to 3 years
Safety Issue:
Yes
Disease-free survival (DFS)
Time Frame:
up to 3 years
Safety Issue:
No
Recurrence rate by year
Time Frame:
up to 3 years
Safety Issue:
No
survival rate by year
Time Frame:
up to 3 years
Safety Issue:
No
Overall survival (OS)
Time Frame:
up to 3 years
Safety Issue:
No
Time to recurrence (TTR)
Time Frame:
up to 3 years
Safety Issue:
No

Trial design

Investigations of Sorafenib for HCC patients who have residue disease after resection with curative intent

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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