NCT03419897已完成2 期
A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma
BeiGene54 个研究点 分布在 8 个国家目标入组 249 人开始时间: 2018年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 54
- 主要终点
- Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
研究概览
简要总结
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HCC
- •Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
- •Has received at least 1 line of systemic therapy for unresectable HCC
- •Has at least 1 measurable lesion as defined per RECIST v1.1
- •Child-Pugh score A
- •Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Adequate organ function
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- •Prior therapies targeting PD-1 or PD-L1
- •Has known brain or leptomeningeal metastasis
- •Tumor thrombus involving main trunk of portal vein or inferior vena cava
- •Loco-regional therapy to the liver within 4 weeks before enrollment
- •Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
- •Has received:
- •Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
- •Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab
Experimental
200 milligrams once every 3 weeks
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
时间窗: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
次要结局
- Progression-free Survival (PFS) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
- PFS Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
- DCR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
- Duration of Response (DOR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
- DOR Event-Free Rate Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported)
- EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
- ORR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
- DOR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
- Clinical Benefit Rate (CBR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
- CBR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
- Overall Survival (OS)(From date of first dose to end of study (up to approximately 4 years and 3 months))
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
- DOR Event-Free Rate Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported)
- Disease Control Rate (DCR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
- Number of Participants With Adverse Events(From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months)
研究者
研究点 (54)
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