Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed

Liver Cancer Clinical Trial

Official title:

Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040898
• Other study ID #: 01-002
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: January 17, 2013
• Start date: January 2001

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the growth of tumor cells and stimulate a person's immune system to help kill tumor cells. This may be an effective treatment following hepatic artery embolization.

PURPOSE: Phase II trial to study the effectiveness of Sho-saiko-to following hepatic artery embolization in treating patients who have liver cancer.

Description:

OBJECTIVES:

• Compare the overall survival of patients with unresectable hepatocellular carcinoma treated with Sho-saiko-to after ablation therapy with embolization vs historical control patients.

• Compare the liver function and alpha fetoprotein levels in patients treated with this drug vs historical control patients.

• Compare the intervention-free survival in patients treated with this drug vs historical control patients.

OUTLINE: Beginning within 1 week after the first course of ablation therapy with embolization, patients receive oral Sho-saiko-to three times daily. Treatment with Sho-saiko-to continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18-24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• One of the following conditions:

• Histologically confirmed unresectable hepatocellular carcinoma

• Serum alpha-fetoprotein (AFP) level greater than 500 ng/mL with cirrhosis

• Serum AFP level greater than 500 ng/mL with a liver mass and positive hepatitis B or C serology

• Receiving ablation therapy with embolization

• Extrahepatic disease allowed

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 50,000/mm^3

• Hemoglobin greater than 8.0 g/dL

Hepatic:

• See Disease Characteristics

• Bilirubin less than 2.0 mg/dL

• SGOT or SGPT less than 5 times upper limit of normal (ULN)

• PT or INR less than 1.6 times ULN (if not receiving warfarin for anticoagulation)

• Albumin greater than 2.5 g/dL

Renal:

• Creatinine less than 1.8 mg/dL

Pulmonary:

• DLCO at least 50% predicted OR

• DLCO at least 70% predicted if total lung capacity less than 80% predicted

• No significant lung disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No uncontrolled infection or pain

• No other condition that would significantly impair cognitive functioning during the study

• No overt psychosis, mental disability, or other incompetency that would preclude study

• No other life-threatening illness for which the prognosis is poorer than for hepatocellular carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent interferon

Chemotherapy:

• No prior chemotherapy within 4 weeks of initiating ablation therapy

• No concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy within 4 weeks of initiating ablation therapy

• Concurrent radiotherapy allowed

Surgery:

• See Disease Characteristics

Other:

• See Disease Characteristics

• No prior ablation therapy

• No other concurrent Sho-saiko-to or any of its constituent plants

• No other concurrent anticancer medications

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Dietary Supplement:
• Sho-saiko-to

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,