NCT00040898

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

July 8, 2002

Last Update Submit

January 17, 2013

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinoma

Interventions

Sho-saiko-toDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

shosaiko-to

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ronald DeMatteo, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

January 1, 2001

Primary Completion

January 1, 2006

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)