NCT04741165Unknown2 期
An Open-label, Multicenter, Phase II Clinical Study of HX008 in Combination With Bevacizumab or Lenvatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Taizhou Hanzhong biomedical co. LTD13 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年1月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 72
- 试验地点
- 13
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understood and signed an informed consent form.
- •Age ≥ 18 and ≤ 75 years old, male or female.
- •Has histologically- or cytologically-confirmed diagnosis of unresectable hepatocellular carcinoma.
- •Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach.
- •Child-Pugh class A and B (≤7 points).
- •Has not received any systematic treatment for HCC.
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
- •Life expectancy ≥ 3 months.
- •Has at least one measurable disease based on RECIST 1.
- •Has adequate organ function as defined in the protocol.
- •Female participants of childbearing potential should have a negative pregnancy within 7 days before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
排除标准
- •Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- •Diagnosed additional malignancy within 3 years prior to the first dose of trial, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervical or non-muscle invasive bladder cancers.
- •Has received locoregional therapy or surgery within 4 weeks prior to the first dose of trial treatment; received palliative radiotherapy or herbal medicine within 2 weeks prior to the first dose of trial treatment;
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •HBV-DNA>2000 IU/mL or 10^4 copy/mL; HCV-RNA>10^3 copy/mL.
- •Has had esophageal or gastric variceal bleeding within the last 6 months.
- •Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
- •Other obvious hemorrhagic tendency or evidence on important coagulation disorder.
- •Serious cardiovascular and cerebrovascular diseases.
- •Inability to swallow tablets, malabsorption syndrome or any other condition that affects gastrointestinal absorption.
- •Serious, uncured wound, active ulcer or untreated bone fracture.
- •Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate peritoneal effusion at screening.
- •Has active autoimmune disease that has required systemic treatment in past 2 years.
- •Has received a major surgery within 4 weeks prior to the first dose of tiral treatment.
- •Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
- •Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis.
- •Has known active tuberculosis (Bacillus tuberculosis)
- •Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
- •Co-infection of HBV and HCV.
- •Any serious acute and chronic infection within 4 weeks prior to the first dose of trial treatment, or infection requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to the first dose of trial treatment.
- •Has participated in other anticancer drug clinical trials within 4 weeks.
- •Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
Experimental: HX008+Bevacizumab
Experimental
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.
干预措施: HX008 (Drug)
Experimental: HX008+Bevacizumab
Experimental
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.
干预措施: Bevacizumab (Drug)
Experimental: HX008+Lenvatinib
Experimental
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD).
干预措施: HX008 (Drug)
Experimental: HX008+Lenvatinib
Experimental
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD).
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 15 months
ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
次要结局
- Time to Disease Progression (TTP)(up to approximately 15 months)
- Disease Control Rate (DCR)(up to approximately 15 months)
- Progression-free Survival (PFS)(up to approximately 15 months)
- Overall Survival (OS)(up to approximately 20 months)
- Number of participants with adverse events (AEs)(up to approximately 20 months)
- Duration of Response (DOR)(up to approximately 15 months)
研究者
研究点 (13)
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