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Completed

NCT Number: NCT01839630

Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Primary outcomes

  1. Summarized patient characteristics

    Time frame: up to 3 years

    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.

Secondary outcomes

  1. Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability

    Time frame: up to 3 years

  2. overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients

    Time frame: up to 3 years

  3. progression-free survival (PFS) by the mRECIST for treatment of uHCC patients

    Time frame: up to 3 years

  4. time to progression (TTP) by the mRECIST for treatment of uHCC patients

    Time frame: up to 3 years

  5. response rate (RR) by the mRECIST for treatment of uHCC patients

    Time frame: up to 3 years

  6. Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients

    Time frame: up to 3 years

  7. Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients

    Time frame: up to 3 years

  8. Treatment pattern of Sorafenib

    Time frame: up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)

Acronym: SUCCESS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2013
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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