Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT06519721
- Lead Sponsor
- RenJi Hospital
- 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 observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.
Sample Size:
According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.
Study Subjects:
Patients with advanced HCC
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1: Accelerated titration phase Lenvatinib Combined with VIC-1911 Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen. Phase 2: Expansion phase Lenvatinib Combined with VIC-1911 According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 2 years Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 2 years Overall Survival (OS) is defined as the percentage of patients in a study or a group of patients who are alive for a certain period of time after the start of treatment.
Progression-Free Survival (PFS) 2 years Progression-Free Survival (PFS) is defined as the length of time during a study that a patient with a known cancer diagnosis does not experience disease worsening or death due to the disease.
Trial Locations
- Locations (1)
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, China