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Study of Unresectable HCC Treated Concomitantly With TACE and Sorafenib in Chinese Patients

Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

Study of Unresectable HCC Treated Concomitantly With TACE and Sorafenib in Chinese Patients

Inclusion Criteria:

- Patients with histologically/ cytologically documented or radiographically diagnosed
unresectable HCC who are candidates for systemic therapy and for whom a decision to
treat with sorafenib has been made. Radiographic diagnosis needs typical findings of
HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic
arteriography (CTHA)/CT arterial portography (CTAP) or MRI;

- Patients receive the first dose of sorafenib no later than 1 week (<=7days) after the
3rd TACE procedure

- Patients did not receive other prior systemic treatment by using target therapy

- Patients must sign the informed consent form;

- Patients must have a life expectancy of at least 3 months;

- The physician must be willing to complete and submit all CRFs;

- The physician must be willing to submit to a site audit with verification of source
documents and validation of data reported;

Exclusion Criteria:

- The first dose of sorafenib 7 days after the 3nd TACE procedure

- Exclusion criteria must follow the approved local product information

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Summarized patient characteristics

Outcome Description:

Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.

Outcome Time Frame:

up to 3 years

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

September 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • Sorafenib
  • Hepatocellular cancer
  • TACE combination
  • Treatment pattern
  • Safety
  • Effectiveness
  • Carcinoma
  • Carcinoma, Hepatocellular