Clinical trial · Interventional
Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma
A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
NCT01817205CI-TRIAL-00040347terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor case accrual
Summary
Brief summary (as posted)
The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE with Hyperthermia Treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- TACE with Hyperthermia treatment
- description
- Interventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE.
- interventionNames
- Procedure: TACE with Hyperthermia Treatment
Primary outcomes (1)
- measure
- dose limiting toxicity
- timeFrame
- 30 days from the study treatment
Secondary outcomes (3)
- measure
- adverse event of treatment
- timeFrame
- within 6 months of treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patient factor * Age between 18 and 75 * Child-Pugh A cirrhosis * Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below * No serious concurrent medical illness * Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed * Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment * Platelet count ≥ 50 10\^9/L Tumor factor * HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology * Unresectable and locally advanced disease without extra-hepatic disease * Hypervascular lesions on CT * Greatest dimension of the largest tumor ≤15cm Exclusion Criteria: Patient factor * History of significant concurrent medical illness such as ischemic heart disease or heart failure * Metallic body implants, not including dental fillings * Serum creatinine level \> 130 umol/L * Presence of biliary obstruction not amenable to drainage * Child-Pugh B or C cirrhosis * Unable to give consent Evidence of impaired liver function * History of hepatic encephalopathy * Intractable ascites not controllable by medical therapy * History of variceal bleeding within last 3 months * Serum total bilirubin level \>25 umol/L for the first 5 patients, serum total bilirubin level \>35 umol/L for the second 5 patients * Serum albumin level \< 30g/L * International normalized ratio(INR) \>1.3 Tumor factor * Presence of extrahepatic metastasis * Infiltrative lesion Vascular invasion * Hepatic artery thrombosis * Partial or complete thrombosis of the main portal vein * Tumor invasion of portal branch of contralateral lobe * Hepatic vein tumor thrombus * Significant arterioportal shunt * Significant arteriovenous shunt Contraindication for hyperthermia * Known brain metastasis * Recent stroke or cerebral hemorrhage within last 6 months * Poorly controlled epilepsy * Poorly controlled cardiac arrhythmias * Myocardial infarction within last 6 months * Unstable angina within last 6 months * Poorly controlled hypertension * Poorly controlled diabetes * History of malignant hyperthermia * Photodermatosis * Pregnancy * Lactation * Serious infection * Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events * Elevation of serum alanine transaminase ≥ 10 times upper limit of normal
References
Publications (0)
Data not yet available
No reference posted for this study.