An observational study in Carcinoma, Hepatocellular, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Bayer · Observational
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 106 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
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HCC patients with residue disease after resection with curative intent
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.
Exclusion Criteria:
Drug: Sorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator.
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
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
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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