Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatment sorafenib (nexavar, bay43-9006)
Sponsor Bayer
Start date July 2013
End date December 2016
Trial size 106 participants
Trial identifier NCT01751763, 16621, NX1218CN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
sorafenib (nexavar, bay43-9006)
treatment (including dose, duration, modification) decided by the investigator.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.