Clinical trial · Interventional
M-TACE Treatment for Unresectable Hepatocellular Carcinoma
Lipiodol Combined With Microspheres TACE for Unresectable HCC
NCT05875558CI-TRIAL-00066685unknownN/AClinicalTrials.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)
This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(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 |
|---|---|---|---|
| M-TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M-TACE
- interventionNames
- Procedure: M-TACE
Primary outcomes (2)
- measure
- ORR
- timeFrame
- 1 month after first mTACE
- description
- Objective response rate according to the mRECIST
- measure
- ORR
- timeFrame
- 3 months after first mTACE
- description
- Objective response rate according to the mRECIST
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18≤Age\<80 on day of signing informed consent. 2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion. 3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy. 4. Have a Child-Pugh Class A/B（\<7） liver score. 5. Have a performance status of 0 or 1 using the ECOG. 6. Have a predicted life expectancy of greater than 3 months. Exclusion Criteria: 1. The targeted lesions have received TACE or other locoregional therapy within 3 months. 2. Tumor burden over 70% of the liver volume. 3. Lesions can not be measured by mRECIST. 4. Has a diagnosed additional malignancy. 5. Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min. 6. Severe heart, lung or cerebral disease.
References
Publications (0)
Data not yet available
No reference posted for this study.