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Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent

18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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

Outcome Time Frame:

up to 1 year

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

February 2015

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular