Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.

Official Title
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A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma

Conditions
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Hepatectomy, Hepatocellular Carcinoma, Sorafenib

Intervention / Treatment
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* Procedure: hepatic resection
* Procedure: transcatheter hepatic arterial chemoembolization
* Drug: sorafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, surgery<br>The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy. | Procedure: hepatic resection<br>* palliative hepatectomy followed by sorafenib<br>* Other names: Group A (hepatectomy);|
| Experimental: B, TACE<br>Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy. | Procedure: transcatheter hepatic arterial chemoembolization<br>* TACE followed by sorafenib<br>* Other names: Group B (TACE);|
| Experimental: C, sorafenib<br>Patients in group C will receive monotherapy of sorafenib. | Drug: sorafenib<br>* sorafenib monotherapy, 400mg Bid, continuously<br>* Other names: Group C (sorafenib);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | defined as the time from the first treatment to death | anticipate 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | defined as the time from the first treatment to the first progression disease is confirmed by radiological methods | anticipate 3-6 months | 
| AEs and SAEs | according to CTC AE 3.0 | anticipate 6-12 months | 
| cost of treatments | to compare costs of different treatments | 3 months in average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, treatments, survival