Status:
UNKNOWN
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stag...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04490694
Start Date
March 1 2020
End Date
August 1 2023
Last Update
September 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Shanghai, Shanghai Municipality, China, 200032