NCT05220267进行中（未招募）2 期
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年2月28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
- 44
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily joined the study and signed informed consent;
- •Aged > 18 years;
- •ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.
- •Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
- •Patients must have measurable lesions as defined by the RECIST 1.1 standard;
- •Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:
- •Absolute neutrophil count (ANC) ≥1.5x 109/L
- •Lymphocyte count ≥ 500/uL.
- •Platelet count ≥ 80x109/L.
- •Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN.
- •Serum bilirubin ≤ 1.5 x ULN.
- •Creatinine clearance ≥ 60 mL/min.
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab.
- •Signed informed consent form.
- •Ability and capacity to comply with study and follow-up procedures.
排除标准
- •Those who are known to be allergic to pharmaceutical ingredients.
- •Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1;
- •Previous use of anlotinib or other angiogenesis inhibitors
- •The patient has any active autoimmune disease or a history of autoimmune disease;
- •There are uncontrolled heart clinical symptoms or diseases;
- •Patients with congenital or acquired immune deficiency;
- •Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;
- •A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;
- •Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism;
- •Those with active bleeding or bleeding tendency;
- •Presence of a drug uncontrolled hypertension;
- •Urine routine indicates more than urinary protein 2+;
- •Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study;
- •Patients suspected of having other primary cancers;
- •Those who are known to be allergic to pharmaceutical ingredients.
- •Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day
- •Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
- •Pregnant or lactating women.
研究组 & 干预措施
Anlotinib plus Sintilimab
Other
Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).
干预措施: Anlotinib plus Sintilimab (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: up to 2 years
Time from treatment until disease progression or death
次要结局
- objective response rate (ORR)(up to 2 years)
- disease control rate (DCR)(up to 2 years)
- overall survival (OS)(up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 2 years)
研究者
ZHOU FANGJIAN
Director
Sun Yat-sen University
研究点 (1)
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