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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01751763
First received: December 14, 2012
Last updated: May 26, 2017
Last verified: May 2017
December 14, 2012
May 26, 2017
July 9, 2013
December 31, 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 ]
  • 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 ]
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 ]
  • Disease-free survival (DFS) [ Time Frame: up to 3 years ]
  • Recurrence rate by year [ Time Frame: up to 3 years ]
  • survival rate by year [ Time Frame: up to 3 years ]
  • Overall survival (OS) [ Time Frame: up to 3 years ]
  • Time to recurrence (TTR) [ Time Frame: up to 3 years ]
Same as current
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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
Not Provided
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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.
 
Active, not recruiting
106
June 9, 2017
December 31, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01751763
16621
NX1218CN ( Other Identifier: company internal )
No
Not Provided
Not Provided
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Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2017

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