Clinical trial · Interventional
Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)
A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
NCT01409499CI-TRIAL-000347972011PTAHCCcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatectomy | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sorafenib | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic resection | Procedure | — | UNRESOLVED |
| sorafenib | Drug | Sorafenib | ALIAS |
| transcatheter hepatic arterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A, surgery
- description
- The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
- interventionNames
- Procedure: hepatic resection
- type
- EXPERIMENTAL
- label
- B, TACE
- description
- Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.
- interventionNames
- Procedure: transcatheter hepatic arterial chemoembolization
- type
- EXPERIMENTAL
- label
- C, sorafenib
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients \> 18 years of age. * Diagnosed to have advanced HCC (BCLC C stage). * Patients who have a life expectancy of at least 12 weeks. * Patients whose primary tumor can be resected. Definition of resectable in this study: * Tumor number \<=2. * If number of tumors \>= 3, then all tumors were located in the same lobe. * Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein. * Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD. * No major post-operative complication. * Patients who have an ECOG PS of 0, or 1. * Cirrhotic status of Child-Pugh class A only. * The following laboratory parameters: Platelet count \> 60 x 109/L Hemoglobin \> 8.5 g/dL Albumin \> 3.5 g/dL Total bilirubin \< 25μmol/L Alanine transaminase (ALT) and AST \< 2.5 x upper limit of normal Serum creatinine \<1.5 x the upper limit of normal Prothrombin time (PT)\<3 seconds above control. • Patients who give written informed consent. Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from HCC. * History of cardiac disease. * Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) * Known history of human immunodeficiency virus (HIV) infection * Known Central Nervous System tumors including metastatic brain disease. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * History of organ allograft. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Pregnant or breast-feeding patients. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed. * Radiotherapy except for which done for bone metastases palliatively.
References
Publications (0)
Data not yet available
No reference posted for this study.