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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01751763
First received: December 14, 2012
Last updated: September 25, 2014
Last verified: September 2014
  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.


Condition Intervention
Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HCC patients with residue disease after rescetion with curative inten

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751763

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
China
Recruiting
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01751763     History of Changes
Other Study ID Numbers: 16621, NX1218CN
Study First Received: December 14, 2012
Last Updated: September 25, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014