Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent
- 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;
- The approved local product label must be followed for the exclusion criteria