A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites).
In this study, all metastatic tumors will be treated with SABR - a precise, high-dose radiation therapy delivered in 5 sessions. At the same time, participants will receive axitinib (an oral targeted cancer drug) twice daily, and toripalimab (an intravenous immunotherapy) every 3 weeks for up to 2 years.
The study will enroll 48 participants. The main goal is to measure the objective response rate - the proportion of patients whose tumors shrink or disappear after treatment. Researchers will also track how long patients live without their cancer worsening, overall survival, and any side effects from the treatment.
Participants will have regular imaging scans, blood tests, and quality-of-life assessments throughout the treatment and follow-up period.
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
- •Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Radiological evidence of distant metastasis meeting the MD Anderson (MDA) definition of oligometastatic disease: ≤5 metastatic lesions, all amenable to curative-intent local therapy. Lesions must be measurable per RECIST 1.1 criteria.
- •Prior definitive local therapy to the primary tumor, including surgery, stereotactic radiotherapy, or ablation.
- •Either no prior systemic therapy for metastatic disease (first-line naïve), or prior first-line tyrosine kinase inhibitor (TKI) therapy only with subsequent oligoprogression (≤5 progressive lesions with remaining lesions stable).
- •Adequate organ function:
- •Hemoglobin (Hb) ≥ 80 g/L
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- •Platelet count (PLT) ≥ 75 × 10⁹/L
- •Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
- •Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- •Voluntary written informed consent obtained, with commitment to complete all treatment and follow-up visits.
排除标准
- •Target lesions previously treated with radiotherapy with a biologically effective dose (BED₃) ≥ 60 Gy (calculated with α/β = 3 Gy).
- •Target lesions deemed unsuitable for radiotherapy by the treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
- •Uncontrolled malignant pleural effusion or ascites.
- •Presence of other uncured malignancies.
- •History of severe psychiatric illness interfering with understanding of informed consent or compliance with study procedures.
- •Severe cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, uncontrolled arrhythmia, or myocardial infarction within the past 6 months.
- •Any other serious medical condition that, in the investigator's judgment, may pose significant risk or interfere with radiotherapy.
- •Pregnancy, breastfeeding, or planned pregnancy during the study period.
- •Any other reason determined by the investigator that makes the participant unsuitable for study participation.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment to the end of treatment (up to approximately 2 years)
次要结局
- Local Control Rate(From enrollment to the end of treatment (up to approximately 2 years))
- Disease Control Rate (DCR)(From enrollment to the end of treatment (up to approximately 2 years))
- Progression-Free Survival (PFS)(From first SABR to disease progression or death, whichever occurs first (up to approximately 4 years))
- Overall Survival (OS)(From first SABR to death from any cause (up to approximately 4 years))
- Safety (Adverse Events)(From first dose of study treatment to 30 days after last dose (up to approximately 2.5 years))