Sorafenib for Residue Disease After Resection With Curative Intent (SECURE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01751763
First received: December 14, 2012
Last updated: July 2, 2014
Last verified: July 2014

December 14, 2012
July 2, 2014
July 2013
December 2016   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01751763 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Disease-free survival (DFS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Recurrence rate by year [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • survival rate by year [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Time to recurrence (TTR) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
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Sorafenib for Residue Disease After Resection With Curative Intent
Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HCC patients with residue disease after rescetion with curative inten

Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
China
 
NCT01751763
16621, NX1218CN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP