Hepatocellular Carcinoma
Conditions
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
Interventions
DRUGLenvatinib Combined with VIC-1911
Oral administration: Lenvatinib: Take the clinically normal dose: ≤60Kg body weight, 8mg/day; \>60Kg body weight, 12mg/day; VIC-1911: Phase 1: Accelerated titration phase 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 According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
Sponsors
RenJi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed