Clinical trial · Interventional
Chemoembolization for Hepatocellular Carcinoma
NCT02821533CI-TRIAL-00029189terminatedPhase 2ClinicalTrials.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 aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- TACE using a high dose of cisplatin
- description
- Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.
- interventionNames
- Procedure: TACE
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 3 months after treatment
- description
- CT scan abdomen will be performed 3 months after the first treatment. Tumor response by CT was classified into complete response (CR), partial response (PR), static disease (SD, and progressive disease (PD) according to European Association for the Study of the Liver (EASL) necrosis guidelines,
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: Patient factor 1. Age \> 18 2. Child-Pugh A or B cirrhosis 3. ECOG performance status Grade 2 or below 4. No serious concurrent medical illness 5. No prior treatment for HCC except for liver resection 6. Creatinine clearance \>55ml/min. Tumor factor 1. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. 2. Unresectable and locally advanced disease without extra-hepatic disease 3. Massive expansive tumor type with measurable lesion on CT 4. Total tumor mass \< 50% liver volume 5. Largest tumor of greatest dimension ≤ 15cm Exclusion Criteria: Patient factor 1. Serum creatinine level \> 130 umol/L 2. Presence of biliary obstruction not amenable to percutaneous drainage 3. Child-Pugh C cirrhosis Evidence of impaired liver function 1. History of hepatic encephalopathy, or 2. Intractable ascites not controllable by medical therapy, or 3. History of variceal bleeding within last 3 months, or 4. Serum total bilirubin level \> 40 umol/L, or 5. Serum albumin level \< 30g/L, or 6. INR \> 1.3 Tumor factor 1. Presence of extrahepatic metastasis 2. Infiltrative lesion 3. Diffuse lesion Vascular complications 1. Hepatic artery thrombosis, or 2. Partial or complete thrombosis of the main portal vein, or 3. Tumor invasion of portal branch of contralateral lobe, or 4. Hepatic vein tumor thrombus, or 5. Significant arterioportal shunt, or 6. Significant arteriovenous shunt
References
Publications (0)
Data not yet available
No reference posted for this study.