Clinical trial NCT06519721: Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
Official title: Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
References: