NCT00040898CompletedPhase 2
Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 1
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •18 and over
- •Performance status:
- •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
- •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
- •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
- •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
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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