NCT05481463已完成2 期
A Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年1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
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer
详细描述
surufatinib:250mg,QD,Q4W TAS-102:35mg/m2,D1-5,D8-12,Q4W
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
- •Informed consent has been signed
- •Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer
- •Age ≥ 18 years, ≤75 years, male or female
- •ECOG PS：0-1, expected overall survival ≥12 months
- •Patients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens
- •Patients must have at least one measurable liver metastases (RECIST 1.1)
- •No serious organic diseases of the heart, lungs, brain and other organs
- •Patients must have adequate organ and bone marrow function
- •Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration
排除标准
- •Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment
- •Previously received VEGFR inhibitors or immune checkpoint inhibitors
- •Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ
- •Patients previously had brain metastasis or current brain metastasis
- •Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment
- •Clinically significant electrolyte abnormality
- •Patient currently has uncontrolled hypertension, defined as: systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg
- •Proteinuria ≥ 2+ (1.0g/24hr)
- •Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study as judged by the investigator
- •Have evidence or history of bleeding tendency within 3 months, significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment
- •Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification > 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval ≥ 480 ms
- •Active or uncontrolled serious infection (≥CTCAE grade 2 infection)
- •Unrelieved toxic reactions ≥ CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of ≤ grade 2 caused by oxaliplatin
- •Pregnant or lactating women
- •Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk
- •Clinical confirmed human immunodeficiency virus (HIV) infection, history of clinically significant liver disease, including viral hepatitis (hepatitis B / C (HBV DNA Positive[1×104 copies/mL or >2000 IU/ml], HCV RNA positive[>1×103 copies/mL]), or other hepatitis, cirrhosis])
- •Patients with autoimmune disease or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple Sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.)
- •Patients who are allergic or suspected to be allergic to the study drug or similar drugs
- •Patients have other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities. Accompanied by family or social factors, which will affect the safety of patients
研究组 & 干预措施
surufatinib combined with TAS-102
Experimental
Surufatinib 250mg,TAS-102 35mg/m2
干预措施: Surufatinib (Drug)
surufatinib combined with TAS-102
Experimental
Surufatinib 250mg,TAS-102 35mg/m2
干预措施: TAS-102 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to 24 months
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
次要结局
- overall survival (OS)(up to 24 months)
- disease control rate (DCR)(up to 24 months)
- quality of life (QoL)(up to 24 months)
- adverse events (AE)(up to 24 months)
- objective response rate (ORR)(up to 24 months)
研究者
Dong sheng Zhang
Professor
Sun Yat-sen University
研究点 (1)
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