NCT05527821尚未招募2 期
An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月30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
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors
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
- •Age 18-75 years (including 18 and 75 years), both genders;
- •Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment;
- •The lesions can be clearly evaluated by imaging;
- •Expected survival ≥ 12 weeks;
- •No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
- •Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements:
- •If a fertile man or woman is willing to use contraception during the trial;
- •Physical status score ECOG 0-1;
- •Patients or their family members agreed to participate in the study and signed the informed consent form;
排除标准
- •Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
- •Women who are breast feeding, pregnant or preparing to become pregnant;
- •Corticosteroids (dose equivalent to prednisone & GT; 10 mg/ day) or other immunosuppressive therapy;
- •Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group);
- •Allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C reference: HCV RNA≥1×103 copies /ml);
- •Interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
- •Allergic constitution and multiple drug allergy;
- •Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.
研究组 & 干预措施
Surufatinib Combined With Sintilimab and SCRT
Experimental
干预措施: Surufatinib (Drug)
Surufatinib Combined With Sintilimab and SCRT
Experimental
干预措施: Sintilimab (Drug)
Surufatinib Combined With Sintilimab and SCRT
Experimental
干预措施: Short course radiotherapy (Radiation)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From Baseline to primary completion date, about 24 months
A duration from the date of initial treatment to disease progression or death of any cause
次要结局
- Objective response rate (ORR)(From Baseline to primary completion date, about 24 months)
- Overall survival (OS)(From the time of enrollment to death caused by any reason)
- Disease Control Rate(From Baseline to primary completion date, about 24 months)
- The incidence of adverse events(From Baseline to primary completion date, about 24 months)
研究者
Xiaorong Dong
Director
Wuhan Union Hospital, China
研究点 (1)
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