Clinical trial · Interventional
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
NCT04490694CI-TRIAL-00054070unknownPhase 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)
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
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 |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE Combined with Lenvatinib
- interventionNames
- Drug: Lenvatinib
- Procedure: TACE
Primary outcomes (2)
- measure
- Time to progression（TTP）
- timeFrame
- 2 years
- description
- The time from the beginning of randomization to the tumor progression of the patient
- measure
- Objective remission rate（ORR）
- timeFrame
- 2 years
- description
- ORR according to modified RECIST for Hepatocellular Carcinoma
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma. 2\. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores \<7. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient and/or his family agreed to join the clinical trial and sign the informed consent form. Exclusion Criteria: * 1\. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation). 2\. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation. 4\. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy. 5\. Estimated life expectancy of \<3 months. 6. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil\<1.5×109/L, PLT\<50×109/L. The INR\>2.3. 7\. Renal dysfunction：serum creatinine (SCR) \>176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) \<30 mL/min. 8\. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or lactating women. 10. cannot cooperate with TACE operation and sign informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.