check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

16608

ClinicalTrials.gov Identifier:

NCT01839630

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sorafenib concomitantly used with TACE (Transarterial Chemoembolization) in uHCC (unresectable hepatocellular carcinoma) patients in China

Trial purpose

This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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;
  • - The first dose of sorafenib 7 days after the 3nd TACE procedure
    - Exclusion criteria must follow the approved local product information

Trial summary

Enrollment Goal
302
Trial Dates
May 2013 - December 2016
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Summarized patient characteristics
    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.
    date_rangeTime Frame:
    up to 3 years
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    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability
    date_rangeTime Frame:
    up to 3 years
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    Safety Issue:
    Yes
  • overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
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    Safety Issue:
    No
  • progression-free survival (PFS) by the mRECIST for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • time to progression (TTP) by the mRECIST for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • response rate (RR) by the mRECIST for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment pattern of Sorafenib
    Treatment pattern included: Duration and dosage of Sorafenib treatment; reason for Sorafenib dosage modification/discontinuation; anticancer combination therapy; treatment after radiographic relapse; comorbidities and their impact on disease outcome.
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Study on Transarterial chemoembolization combined with Sorafenib in Chinese patients with unresectable hepatocellular carcinoma (SUCCESS)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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