A Multicenter, Randomized Controlled Study Comparing Vorolanib Tablets Plus Everolimus With Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed on Immunotherapy Monotherapy or in Combination With TKI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Progression Free Survival（PFS）
研究概览
简要总结
This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed renal clear cell carcinoma (histological or cytological);
- •Subjects who have failed prior treatment with a single anti-PD-1/PD-L1 agent or a combination of anti-PD-1/PD-L1 and anti-VEGFR TKI;
- •Age 18 to 80 years;
- •Estimated survival exceeding 12 weeks;
- •KPS score ≥70;
- •At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy;
- •Adequate organ function levels;
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; all enrolled subjects (male or female) must use effective barrier contraception throughout treatment and for 4 weeks post-treatment;
- •Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures.
排除标准
- •Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
- •Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
- •Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
- •Subjects with known hypersensitivity to similar drugs;
- •Subjects with active infectious diseases;
- •Any uncontrolled clinical condition;
- •Undergone major surgery within 4 weeks prior to enrollment;
- •History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;
- •Any condition affecting the subject's ability to swallow medication;
- •Pregnant or lactating women;
- •Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment;
- •Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.
研究组 & 干预措施
Vorolanib Tablets+Everolimus
干预措施: Vorolanib Tablets+Everolimus (Drug)
Sunitinib
干预措施: Sunitinib (Drug)
结局指标
主要结局
Progression Free Survival（PFS）
时间窗: The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.
The time from study entry to the first disease progression (PD) or death from any cause, as assessed by the investigator.
次要结局
- Overall Survival（OS）(The duration of treatment is determined from the start date to the date of death, or the last visit date serves.Estimate up to 3 years)
- Objective Response Rate（ORR）(From the start of receiving the treatment regimen in this study until the subject's disease progression and subsequent withdrawal from the study.Estimate up to 2 years)
- Disease Control Rate（DCR）(Estimate up to 2 years)
- Duration of Relief (DOR)(The time from the first assessment of tumor response as CR or PR (whichever occurs first) to the first assessment of PD or death from any cause (whichever occurs first).Estimate up to 2 years.)
- Adverse Events (AE)(about 2 years)
研究者
Jun GUO
Associate Director of Peking University Cancer Hospital
Peking University Cancer Hospital & Institute