- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490694
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TACE Combined with Lenvatinib
|
Intervention Description:lenvatinib will be administered daily (for patients <60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Other Names:
Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg).
Gelatin sponge particles / microspheres are used to strengthen embolization.
Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to progression(TTP)
Time Frame: 2 years
|
The time from the beginning of randomization to the tumor progression of the patient
|
2 years
|
Objective remission rate(ORR)
Time Frame: 2 years
|
ORR according to modified RECIST for Hepatocellular Carcinoma
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 2 years
|
Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
|
2 years
|
Overall survival
Time Frame: 5 years
|
the survival time after randomization
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhiping Yan, M.D., Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Lenvatinib
Other Study ID Numbers
- B2019-151R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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