Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC (NCT06519721) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
China12 participantsStarted 2024-08-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 componen…