Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

Официальное название

Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial

Обзор

Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.

Подробное описание

Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy ( perioperative TACE treatment，camrelizumab and apatinib, 2 cycles), radical surgery, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.

Вмешательства

• Препарат Camrelizumab
  Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
• Препарат Apatinib Mesylate
  Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
• Процедура Radical surgery
  Radical surgery
• Процедура Preoperative TACE treatment
  TACE treatment before preoperative camrelizumab combined with apatinib mesylate
• Препарат Camrelizumab
  Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
• Препарат Apatinib Mesylate
  Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery

Первичные конечные точки

• 2 year event-free survival（2y-EFS） [Срок оценки: 2-year]

Вторичные конечные точки (7)

• R0 resection rate [Срок оценки: 30-day]
• The rate of subjects of major pathological response (MPR) [Срок оценки: 30-day]
• the rate of subjects with pathological complete response (pCR) [Срок оценки: 30-day]
• Overall survival (OS) [Срок оценки: 3-year]
• Event-free survival (EFS) [Срок оценки: 3-year]
• Disease-free survival (DFS) [Срок оценки: 3-year]
• Adverse event (AE) [Срок оценки: 3-year]

Критерии участия

Критерии включения

• Volunteer to participate in this study and sign an informed consent form.
• Age ≥18 years old, no gender limit.
• Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
• CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
• Child-Pugh score: A grade (≤6 points).
• ECOG PS score: 0-1 points.

Критерии исключения

• Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
• Currently accompanied by interstitial pneumonia or interstitial lung disease.
• Existence of active autoimmune disease or history of autoimmune disease and may relapse.
• Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count >15\*10\^9/L.
• Patients with congenital or acquired immune deficiencies (such as HIV-infected persons).
• Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients.

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

• Jiangsu Province Hospital — Нанкин

Идентификаторы

NCT: NCT05613478 · 2022-SR-558

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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