A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Официальное название

A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Обзор

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.

Вмешательства

• Препарат QL1706
  7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Препарат Bevacizumab
  15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Препарат Oxaliplatin injection
  85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
• Препарат Capecitabine
  1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
• Препарат Sintilimab
  200 mg administered as IV infusion on Day 1 of each 21-day cycle

Первичные конечные точки

• Objective Response Rate (ORR) (Phase II) [Срок оценки: Up to approximately 4 years]
• Incidence of Adverse Events (AEs) (Phase II) [Срок оценки: Up to approximately 4 years]
• Overall Survival (OS) (Phase III) [Срок оценки: Up to approximately 4 years]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 4 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 4 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 4 years]
• Time to progression (TTP) [Срок оценки: Up to approximately 4 years]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 4 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 4 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 4 years]
• Time to progression (TTP) [Срок оценки: Up to approximately 4 years]

Критерии участия

Критерии включения

• Subjects participate voluntarily and sign informed consent.
• Age ≥ 18 and ≤ 80 years old, male or female.
• Histological or cytological or clinical diagnosis of HCC
• Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
• No prior systemic therapy for HCC.
• Child-Pugh ≤7 , no history of hepatic encephalopathy.

Критерии исключения

• Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
• History of malignancy other than HCC within 5 years prior to the start of study treatment.
• History of liver transplantation, or planned to receive liver transplantation.
• Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.

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 · 2 центра

• Nanjing Tianyinshan Hospital — Нанкин
• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT05976568 · QL1706-308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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