Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- •Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
- •No previous systemic anticancer treatment or TACE treatment
- •Age ≥18 years
- •ECOG performance status: 0-1
- •Child Pugh score≤7
- •Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
- •Life expectancy ≥12 weeks.
- •Patients must be able to understand and willing to sign a written informed consent document
排除标准
- •Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
- •History of hepatic encephalopathy or liver transplantation
- •Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
- •Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
- •With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.
- •Evidence of active pulmonary tuberculosis (TB).
- •Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •History of allergic reactions to related drugs
- •Pregnant women, nursing mothers
研究组 & 干预措施
Sintilimab Plus Lenvatinib
Participants receive 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) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: Sintilimab (Biological)
Sintilimab Plus Lenvatinib
Participants receive 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) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 1 year after the last patient's enrollment
次要结局
- Overall Survival(2 years after the last patient's enrollment)
- Tumor mutation burden in association with ORR and survival.(1 year after the last patient's enrollment)
- Conversion rate to surgery(1 year after the last patient's enrollment)
- Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).(2 years after the last patient's enrollment)
研究者
Baocai Xing
Professor
Peking University Cancer Hospital & Institute