Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT00805896 | Unknown Phase 2 DMC

• 1 other identifier: LCI-1001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatocellular Carcinoma; Unresectable

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression(TTP)

  Dec 2008 to Dec 2010

Secondary Outcomes (1)

• Overall survival (OS)

  Dec 2008 to Dec 2010

Study Arms (2)

1

EXPERIMENTAL

Songyou Granule

Drug: Songyou

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Songyou DRUG

4g/pack

1

placebo DRUG

4g/pack

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Liver Cancer Institute and Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

songyou yin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zhao-You Tang, MD

  Fudan University

  STUDY CHAIR

• Boheng Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 31, 2008

Record last verified: 2008-12

Locations

CN (2)