Clinical trial · Interventional
Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
NCT00040898CI-TRIAL-00009011completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sho-saiko-to | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.