NCT05064852Unknown不适用
A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC).
详细描述
This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC). About 200 subjects are prepared to recruit in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18, male or female;
- •Patients with histologically or cytologically confirmed unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC); Surgical resection with positive margins are allowed;
- •ECOG score 0-2;
- •Expected survival of ≥12 weeks;
- •Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1;
- •It is not less than 7 days since the end of the last systematic treatment, and the palliative treatment of the limited area is allowed
- •Treatment has been over 4 weeks;
- •The function of major organs and bone marrow was basically normal;
- •Fully understand this study, voluntarily participate in it, and sign the informed consent.
- •Fertile male or female patients shall volunteer to use effective contraceptive methods, such as double barrier contraception, condoms, oral or injected contraceptives, and intrauterine devices, during the study period and within 90 days after the last dosing of the investigational drug. All-female patients will be considered fertile unless they have had natural menopause, or artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or ovarian radiation)
排除标准
- •Fine basal skin that has been diagnosed with other malignant tumors within the past 5 years and has been effectively treated (Except for cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer and breast cancer after effective resection outside);
- •Receiving other investigational drugs or approved or under development antitumor therapies;
- •Patients with contraindications to Surufatinib (e.g., active bleeding, ulcers, intestinal perforation, bowel)Obstruction, medically uncontrolled hypertension, grade III-IV cardiac dysfunction, major surgery within 30 days, severe liver and kidney insufficiency, etc.);
- •The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take it orally Surufatinib;
- •Demonstrated allergy to any component of the test drug and/or its excipients;
- •Pregnant (positive pregnancy test before dosing) or breast-feeding women;
- •Patients with large pleural effusion or ascites requiring drainage;
- •Taken a drug containing hyperforin perforatum within 3 weeks prior to the first study, or before taken other CYP3A4 strong inducer or inhibitor within 2 weeks;
- •The investigator determined that liver metastases accounted for 50% or more of the total volume of the liver;
- •Clinically intervened biliary obstruction was not in remission or required anti-infective therapy as determined by the investigator 14 days prior to the first study drug treatment;
- •Previous liver transplantation;
- •Clinically significant electrolyte abnormalities as determined by the investigator;
- •Any other diseases with clinically significant metabolic abnormalities, abnormal physical observations, or abnormal laboratory findings, which are judged by the investigator as evidence that the patient has a disease or condition that is unsuitable for the study drug (e.g., epileptic seizures requiring treatment), or that would interfere with the interpretation of the study results, or that may put the patient at high risk.
研究组 & 干预措施
Surufatinib
Patients with BTC visited the site from 2021 to 2023 and received Surufatinib therapy.
干预措施: Surufatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 6 months after the last patient enrolled
PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.
次要结局
- Disease Control Rate(DCR)(6 months after the last patient enrolled)
- Overall survival (OS)(6 months after the last patient enrolled)
- Objective Response Rate (ORR)(6 months after the last patient enrolled)
- Safty(up to 4 weeks after the last dose)
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