Clinical trial · Observational
Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Summarized patient characteristics
- timeFrame
- up to 3 years
- 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.
Secondary outcomes (8)
- measure
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability
- timeFrame
- up to 3 years
- measure
- overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available