Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Официальное название

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

Обзор

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.

Вмешательства

• Препарат Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
  RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Первичные конечные точки

• Objective Response Rate [Срок оценки: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 12 months]

Вторичные конечные точки (4)

• Progression-free survival [Срок оценки: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months]
• Overall survival [Срок оценки: Through study completion, up to 24 months]
• Disease control rate [Срок оценки: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months]
• Adverse Events [Срок оценки: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).]

Критерии участия

Критерии включения

• 18 years or older.
• HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
• Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
• A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
• No prior treatment for HCC.
• At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Performance status (PS) ECOG score ≤1.
• Child-Pugh score ≤7.
• Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
• Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.

Критерии исключения

• Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
• Previous liver transplantation;
• History of other malignancies;
• Previous history of severe mental illness;
• Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
• Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
• Other reasons were judged by the investigator to be unable to enroll.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT05954897 · KY2023-124-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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