NCT05013515Unknown不适用
A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.
详细描述
The purpose of this study was to explore whether the efficacy and survival time of patients with local advanced primary salivary gland adenocarcinoma could be further improved through the treatment of Surufatinib neoadjuvant for local advanced primary salivary gland adenocarcinoma, and to explore the safety and tolerability of this regimen.A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study.
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
- •Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- •aged between 18 and 75 years are eligible;
- •Male and Female are available；
- •Patients with locally advanced primary salivary gland adenocarcinoma confirmed by pathology or histology (except nasopharyngeal carcinoma);At least one measurable lesion (≥10mm on spiral CT scan, meeting RECIST 1.1 criteria);
- •Patients have not received chemotherapy or radiotherapy, targeted therapy, or surgery for any previous reason;
- •Patients with indications for surgery；
- •Primary TNM stage Ⅲ-ⅣA (T1-2/N1-2/M0 or T3-4A/CN0-2 /M0, AJCC2018);
- •Patients should not be accompanied by any other anticancer therapy;
- •It is not concomitant with long-term treatment (≥3 months) with ≥20mg daily dose of methylprednisolone or equivalent dose of corticosteroids;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Predicted survival ≥12 weeks;
- •Screening laboratory values must meet the following criteria (within past 14 days):
- •neutrophils ≥3.0×109/L ;
- •platelets ≥100×109/L；
- •hemoglobin ≥ 9.0 g/dL;
- •albumin≥3g/dL；
- •total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; Endogenous creatinine clearance >50ml/min (Cockcroft- Gault formula);
- •Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
排除标准
- •Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months;
- •Prior antitumor therapy with chemotherapy, radical radiation therapy ，biological immunotherapy，targeted therapy within 4 weeks.
- •Prior participation in other clinical trials not approved or listed in China within past 4 weeks；
- •Prior major surgery within past 4 weeks (Venous catheterization, puncture and drainage are excluded);
- •International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN;
- •Clinically significant severe electrolyte abnormality judged by investigator ;
- •Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
- •Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L);
- •The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
- •Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation;
- •Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month;
- •Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ，Coronary Artery Bypass Grafting within past 6 months,)；
- •Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- •Active or uncontrolled severe infection (≥CTCAE2 infection);
- •Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml);
- •Evidence with active CNS disease or previous brain metastases;
- •The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin;
- •Pregnant or nursing;
- •Transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF), had been received within 14 days before enrollment;
- •Tumor involving skin and/or pharyngeal mucosa with ulceration;
- •Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders;
- •Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to doubt is not suitable for the use of study drugs in patients with a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or make the patients at high risk.
- •Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g;
- •Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events
研究组 & 干预措施
Salivary Gland Carcinomas
Experimental
Patients with Salivary Gland Carcinomas were given Surufatinib .
干预措施: Surufatinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
次要结局
- Major pathological response rate (MPR)(up to 12 months)
- Overall survival time(through study completion, an average of 1 year)
- Assess the anti-tumor activity:DCR(up to 12 months)
- Progression Free Survival (PFS)(up to 36 months)
研究者
研究点 (1)
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