Liver CancerPhase 2NCT00040898
Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
A Phase 2 study testing Sho-saiko-to in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Sho-saiko-to
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- Sho-saiko-to
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sho-saiko-toDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2001
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald DeMatteo, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040898
- Sponsor's protocol ID
- 01-002
- Other IDs
- P30CA008748, MSKCC-01002, NCI-G02-2084
- Status last verified
- Jan 2013
- First submitted
- 8 Jul 2002
- Last updated
- 18 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
- ClinicalTrials.gov ID
- NCT00040898
- Acronym / sponsor ID
- 01-002
- Conditions
- Liver Cancer
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2001
- Primary completion
- Jan 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sho-saiko-to | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald DeMatteo, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sho-saiko-to in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.