Combining lenvatinib and VIC-1911 for advanced liver cancer treatment

Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced Hepatocellular Carcinoma

This study is testing a new combination of two treatments, lenvatinib and VIC-1911, to see if they can help people with advanced liver cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: lenvatinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT06519721 on ClinicalTrials.gov

What this trial studies

This study is an open-label trial designed to evaluate the safety and efficacy of a combination treatment using lenvatinib and VIC-1911 in patients diagnosed with advanced hepatocellular carcinoma (HCC). The trial will enroll a total of 15 patients, starting with an accelerated titration phase followed by an expansion phase. Participants will be closely monitored for treatment response and any adverse effects associated with the therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with advanced HCC that meets specific clinical diagnostic criteria.

Not a fit: Patients with severe organ dysfunction, active bleeding disorders, or those requiring long-term anticoagulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer, potentially improving survival rates and quality of life.

How similar studies have performed: While this approach is novel, similar studies combining targeted therapies have shown promise in other cancer types, suggesting potential for success.

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.

Where this trial is running

Shanghai

• Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)

Conditions Hepatocellular Carcinoma