Sorafenib for Residue Disease After Resection With Curative Intent

NCT01751763 | Completed

• 2 other identifiers: 16621NX1218CN
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  up to 3 years

Secondary Outcomes (6)

• Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability

  up to 3 years

• Disease-free survival (DFS)

  up to 3 years

• Recurrence rate by year

  up to 3 years

• survival rate by year

  up to 3 years

• Overall survival (OS)

  up to 3 years

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

treatment (including dose, duration, modification) decided by the investigator.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCC patients with residue disease after resection with curative intent

You may qualify if:

• 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;

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: July 9, 2013
• Primary Completion: December 31, 2016
• Study Completion: September 8, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

CN (1)