Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT ID: NCT00805896

Last Updated: 2008-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-12-31

Brief Summary

Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared with TACE.

Detailed Description

Primary outcome Measures:

To evaluate the effect of TACE plus Songyou Granule or TACE plus placebo on TTP

Secondary Outcome Measures:

• Overall survival (OS)
• Progression Free Survival (PFS)
• The overall response rate
• Time to symptomatic Progression
• In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations
• Overall response duration and time to objective response
• Overall disease control rate
• The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial

Enrollment: 260 Study Start Date: January 2009 Study Completion Date: December 2010 Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Conditions

Hepatocellular Carcinoma; Unresectable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Songyou Granule

Group Type: EXPERIMENTAL

Songyou

Intervention Type: DRUG

4g/pack

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

4g/pack

Interventions

Songyou

4g/pack

Intervention Type: DRUG

placebo

4g/pack

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
• Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
• Patient must have quantifiable disease limited to the liver
• Patients must have at least one tumor lesion that meets both of the following criteria:

• The lesion can be accurately measured in at least one dimension according to RECIST criteria
• The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• ECOG performance status (PS) <2
• No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
• No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A or B
• No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
• The following laboratory parameters:

• Platelet count ≥ 50,000/µL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 2 mg/dL
• ASL and AST ≤ 5 x upper limit of normal
• Serum creatinine ≤ 1.5 x upper limit of normal
• INR ≤ 1.5 or a PTT within normal limits
• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria

• Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted
• Renal failure requiring hemo- or peritoneal dialysis
• Child-Pugh C hepatic impairment
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Known central nervous system tumors including metastatic brain disease
• History of organ allograft
• Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Patients unable to swallow oral medications.
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fudan University

Principal Investigators

Zhao-You Tang, MD

Role: STUDY_CHAIR

Fudan University

Boheng Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Liver Cancer Institute and Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LCI-1001

Identifier Type: -

Identifier Source: org_study_id