Status:
RECRUITING
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
Lead Sponsor:
RenJi Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Detailed Description
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer. Purpose of the Study: To ...
Eligibility Criteria
Inclusion
- Gender unrestricted, age 18-75 years;
- HCC conforms to AASLD or EASL clinical diagnostic standards;
- HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
- Liver function Child-Pugh Class A or Class B with a score of 7;
- ECOG score of 0-1;
- Platelet count ≥60×10\^9/L, PT time prolongation ≤6 seconds.
Exclusion
- Irreversible coagulation dysfunction, with obvious bleeding tendency;
- Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
- Patients with unstable or active ulcers, gastrointestinal bleeding;
- Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
- Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
- Patients with hepatic encephalopathy or refractory ascites requiring treatment;
- Human Immunodeficiency Virus (HIV) infection;
- Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load \> 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment;
- Inability to swallow oral medication.
- Gastrointestinal diseases that may affect the absorption or tolerance of the study medication.
- History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening.
- Known allergy to VIC-1911 or its components.
- Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed;
- Other concurrent antitumor treatments;
- The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06519721
Start Date
August 1 2024
End Date
July 31 2026
Last Update
August 9 2024
Active Locations (1)
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1
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127