Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma:HCCSC C01 Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of surufatinib alone or combined with Anti-PD-1 mAb in the treatment of advanced Hepatocellular Carcinoma
详细描述
This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of surufatinib alone or combined with Anti-PD-1 mAb in the treatment of advanced Hepatocellular Carcinoma.
Cohort A: patients with advanced hepatocellular carcinoma who had failed previous standard first-line therapy and could not tolerate or reject existing therapies.Treatment:surufatinib combined with Anti-PD-1 mAb Cohort B: patients with advanced pancreatic cancer who had previously failed standard sencond-line therapy, could not tolerate or reject existing therapies.Treatment:surufatinib alone.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years to 75 years. 2.Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1)： Cohort A: patients with advanced hepatocellular carcinoma who had failed previous standard first-line therapy and could not tolerate or reject existing therapies.
- •Cohort B: patients with advanced hepatocellular carcinoma who had previously failed standard sencond-line therapy, could not tolerate or reject existing therapies.
- •3.Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥80g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate > 50ml/min).
- •4.At least 4 weeks after the last anti-tumor treatment (surgery, chemotherapy, radiotherapy, biotherapy or endocrine therapy) before enrollment.
- •5.Had a life expectancy of at least 3 months. 6.Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or
- •7.Signed informed consent.
排除标准
- •1.In the past or at the same time with other malignant tumors (already cure period of IB or cervical, lower levels of noninvasive basal cell or squamous cell cancer, obtain complete remission (CR) > 10 years of breast cancer, obtain complete remission (CR) > 10 years of malignant melanoma, obtain complete remission (CR) > 5 years except of other malignant tumors).
- •2.Pregnant or lactating female patients. 3.Had a history of clinically significant or uncontrolled heart disease, including but not limited to: (1)Myocardial infarction. (2)Angina.(3)Congestive heart failure above grade 2 of the New York heart association (NYHA).(4)Ventricular arrhythmias requiring continuous treatment.(5)Supraventricular arrhythmias, including uncontrolled atrial fibrillation.
- •4.The patients had mental disorders, and the researchers believed that the patients could not fully or fully understand the possible complications in this study.
- •5.Have a history of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •6.Those who cannot tolerate or may be allergic to the drugs used in this study. 7.Participated in clinical trials of other drugs within the past 1 month. 8.Other factors considered unsuitable for the study.
研究组 & 干预措施
Research Group
Patients with advanced hepatocellular carcinoma who had failed previous standard 1/2-line therapy and could not tolerate or reject existing therapies.
干预措施: Surufatinib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to 12 weeks
Progression-free survival
次要结局
未报告次要终点
研究者
Zhou Fuxiang
Clinical Professor of Zhongnan Hospital
Zhongnan Hospital