A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC

Официальное название

A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy

Обзор

This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).

Подробное описание

Phase II Part A: To evaluate the safety and tolerability of VRT106 in combination with camrelizumab and apatinib at different dose levels in patients with HCC who have failed prior ICIs, and to determine the recommended phase II dose (RP2D).

Phase II Part B: To evaluate the progression-free survival (PFS) of VRT106 in combination with camrelizumab and apatinib at the RP2D versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Phase III: To evaluate the overall survival (OS) of VRT106 in combination with camrelizumab and apatinib versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Вмешательства

• Препарат VRT106
  VRT106,Intravenous infusion
• Препарат VRT106 in combination with camrelizumab and apatinib
  VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
• Препарат Investigator's Choice of Standard of Care
  At the investigator's discretion

Первичные конечные точки

• Incidence of Dose-Limiting Toxicities [Срок оценки: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.]

Вторичные конечные точки (2)

• Progression-Free Survival [Срок оценки: About 2 years]
• Overall survival [Срок оценки: About 2 years]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form (ICF), understand the nature of this study, and agree to comply with and complete all required study procedures.
• Be aged between 18 and 75 years (inclusive) on the date of signing the ICF, regardless of gender.
• Have a histologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), or a clinical diagnosis of advanced HCC according to the Standard for Diagnosis and Treatment of Primary Liver Cancer(2024 Edition).
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Have an anticipated life expectancy of ≥ 3 months.
• Have no severe hematologic, hepatic, renal, coagulation, or cardiac function abnormalities.

Критерии исключения

• Prior receipt of camrelizumab, apatinib, oncolytic viruses, or other gene therapies.
• Receipt of other unapproved investigational drugs/devices within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose administration in this study, or immunocompromised status.
• History of splenectomy.
• Pregnant or breastfeeding women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07589244 · VRT106-CN05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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