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

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: July 8, 2002
Last updated: January 17, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Liver Cancer
Dietary Supplement: Sho-saiko-to
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: January 2001
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 8.0 g/dL


  • 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


  • Creatinine less than 1.8 mg/dL


  • DLCO at least 50% predicted OR
  • DLCO at least 70% predicted if total lung capacity less than 80% predicted
  • No significant lung disease


  • 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


Biologic therapy:

  • No concurrent interferon


  • No prior chemotherapy within 4 weeks of initiating ablation therapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy within 4 weeks of initiating ablation therapy
  • Concurrent radiotherapy allowed


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior ablation therapy
  • No other concurrent Sho-saiko-to or any of its constituent plants
  • No other concurrent anticancer medications
  Contacts and Locations
Please refer to this study by its identifier: NCT00040898

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00040898     History of Changes
Other Study ID Numbers: 01-002, P30CA008748, MSKCC-01002, NCI-G02-2084
Study First Received: July 8, 2002
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on April 23, 2014