check_circleStudy 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
  • - 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;
  • - 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
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    up to 1 year
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    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.
    date_rangeTime Frame:
    up to 3 years
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    Safety Issue:
    No

Secondary Outcome

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