NCT05481476进行中（未招募）2 期
A Single-center, Single-arm, Phase II Clinical Study of Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年12月12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
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
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 sintilimab and AG in first-line therapy of patients with locally advanced or metastatic pancreatic cancer.
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 not previously received systemic therapy for locally advanced or metastatic pancreatic cancer
- •Patients with distant metastases after surgery, who have received one regimen of adjuvant chemotherapy and have recurred > 6 months from adjuvant therapy can be enrolled
- •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 with BRCA1/2 germline mutations
- •Patients with obstructive jaundice but less than expected jaundice
- •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
- •Investigator determines that the liver metastases account for 70% or more of the total liver volume
- •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
- •Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases 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 period 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 sintilimab and AG
Experimental
干预措施: Surufatinib (Drug)
surufatinib combined with sintilimab and AG
Experimental
干预措施: Sintilimab (Drug)
surufatinib combined with sintilimab and AG
Experimental
干预措施: AG (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: up to 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
次要结局
- adverse events (AE)(up to 24 months)
- Progression-Free Survival (PFS)(up to 24 months)
- Molecular markers and imaging parameters predicting therapeutic efficacy(up to 24 months)
- disease control rate (DCR)(up to 24 months)
- overall survival (OS)(up to 24 months)
研究者
Dong sheng Zhang
Professor
Sun Yat-sen University
研究点 (1)
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