Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Официальное название

Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)

Обзор

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.

Вмешательства

• Комбинированный продукт Lenvatinib combined with TACE and Camrelizumab
  Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).

Первичные конечные точки

• Overall survival [Срок оценки: 3-year]

Вторичные конечные точки (6)

• Adverse events [Срок оценки: 2 years]
• Objective response rate [Срок оценки: 2 years]
• Disease control rate [Срок оценки: 2 years]
• Event-free survival [Срок оценки: 2 years]
• Overall survival at 2 years [Срок оценки: 2 years]
• Conversional resection rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Aged between 18 and 75 years.
• Patients with HCC who strictly meet the criteria outlined in the Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosed by histopathology or cytology.
• No prior anticancer therapy for HCC(Excluding patients who have received two or fewer TACE treatments).
• ECOG PS score of 0-1.
• Child-Pugh class A to B.
• BCLC stage C Patients: tumor localized in one half of the liver with portal vein tumor thrombus (Vp1-Vp4 patients without contralateral portal vein tumor thrombus).
• At least one radiographically measurable lesion according to mRECIST.
• For HBsAg-positive patients, HBV-DNA < 2000 IU/ml (10\^4 copies/ml) when undergoing PD-1 monoclonal antibody treatment; HCV RNA negative when HCV antibody is positive.
• Adequate organ function based on laboratory test results.
• Adequate blood pressure control with up to 3 antihypertensive agents, defined as BP ≤ 150/90 mmHg at screening with no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day 1.
• Patients expected to survive more than 3 months.
• Not planning to become pregnant.

Критерии исключения

• Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma.
• Extrahepatic metastasis of HCC.
• Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus).
• Contraindications to TACE or epirubicin.
• Known hypersensitivity to lenvatinib ingredients.
• Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
• Presence of other malignancies.
• Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
• Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia, cardiac insufficiency class III-IV, or LVEF < 50%.
• Abnormal coagulation function or bleeding tendency.
• History of psychiatric disorders or substance abuse.
• HIV infection.
• Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Active infection.
• Poor compliance such as floating population.
• Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
• Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
• Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the first dose.
• Clinically uncontrolled pleural/peritoneal effusion.
• Active chronic hepatitis B or C.
• Vaccination with live vaccines within 30 days prior to the first dose.

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

• HuaXi hospital — Чэнду

Идентификаторы

NCT: NCT05738616 · HX-IRB-AF-03-V1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗