Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC

Официальное название

Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial

Обзор

This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.

Вмешательства

• Препарат Adebrelimab plus Apatinib
  Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
• Препарат Adebrelimab plus Bevacizumab
  Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
• Препарат Camrelizumab plus Apatinib
  camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

Первичные конечные точки

• 12-month overall survival rate [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (8)

• ORR [Срок оценки: Up to approximately 3 years]
• DCR [Срок оценки: Up to approximately 3 years]
• DoR [Срок оценки: Up to approximately 3 years]
• TTR [Срок оценки: Up to approximately 3 years]
• TTP [Срок оценки: Up to approximately 3 years]
• PFS [Срок оценки: Up to approximately 3 years]
• OS [Срок оценки: Up to approximately 3 years]
• safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
• No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
• BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
• At least one measurable lesion per RECIST v1.1
• ECOG Performance Status of 0 or 1
• Child-Pugh class of A5 to B7
• Adequate organ function

Критерии исключения

• Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
• Moderate-to-severe ascites with clinical symptoms
• History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
• Known genetic or acquired hemorrhage or thrombotic tendency
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
• Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
• History of hepatic encephalopathy
• Previous or current presence of metastasis to central nervous system

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

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06360042 · MA-HCC-II-021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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