Clinical trial NCT01409499: Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)
Official title: A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatectomy
Hepatocellular Carcinoma
Sorafenib
Keywords: hepatocellular carcinoma, treatments, survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: anticipate 6-12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: anticipate 3-6 months
measure: AEs and SAEs
timeFrame: anticipate 6-12 months
measure: cost of treatments
timeFrame: 3 months in average
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Minshan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: