Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805896
Recruitment Status : Unknown
Verified December 2008 by Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2008
Last Update Posted : December 31, 2008
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Unresectable Drug: Songyou Drug: placebo Phase 2

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC
Study Start Date : December 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
Songyou Granule
Drug: Songyou
Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Time to tumor progression(TTP) [ Time Frame: Dec 2008 to Dec 2010 ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Dec 2008 to Dec 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805896

China, Shanghai
Cancer Hospital of Fudan University
Shanghai, Shanghai, China, 200032
Liver Cancer Institute and Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Study Chair: Zhao-You Tang, MD Fudan University
Principal Investigator: Boheng Zhang, MD Fudan University

Responsible Party: Boheng Zhang/Liver Cancer Institute, Fudan University Identifier: NCT00805896     History of Changes
Other Study ID Numbers: LCI-1001
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases