Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-Free Survival 1 (PFS1)
研究概览
简要总结
This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
- •Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or >5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.
- •Age between 18-80 years.
- •Expected survival of ≥12 weeks.
- •Measurable disease based on RECIST Version 1.
- •ECOG performance status of 0-2.
排除标准
- •History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.
- •Use of corticosteroids or other immunosuppressants within 14 days before treatment.
- •Autoimmune diseases.
- •History of other malignancies.
- •History of surgery within 28 days before treatment.
- •Allergy to study drug components.
研究组 & 干预措施
Combination Therapy: SABR + Axitinib + Toripalimab
Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab.
SABR: Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied. Treatment duration is 1-5 weeks based on lesion location.
Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects.
Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity.
Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met
干预措施: Stereotactic Ablative Body Radiotherapy (SABR) (Radiation)
Combination Therapy: SABR + Axitinib + Toripalimab
Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab.
SABR: Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied. Treatment duration is 1-5 weeks based on lesion location.
Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects.
Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity.
Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met
干预措施: TORIPALIMAB INJECTION(JS001 ) (Drug)
Combination Therapy: SABR + Axitinib + Toripalimab
Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab.
SABR: Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied. Treatment duration is 1-5 weeks based on lesion location.
Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects.
Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity.
Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met
干预措施: Axitinib (VEGF-TKI) (Drug)
结局指标
主要结局
Progression-Free Survival 1 (PFS1)
时间窗: From the start of SABR treatment to the first disease progression, up to 2 years. This primary endpoint assesses how long patients survive without disease progression while receiving the combination therapy.
PFS1 is defined as the time from the initiation of stereotactic ablative body radiotherapy (SABR) to the first occurrence of disease progression, as determined by radiological imaging (CT, MRI, or PET/CT) based on RECIST criteria. Disease progression is defined as an increase in the size of target lesions or the appearance of new lesions.
次要结局
- Overall Survival (OS)(From the start of treatment to death or until the end of the study (up to 3 years). This secondary endpoint will help evaluate the overall survival benefits of the combined treatment over a longer period.)
- Progression-Free Survival 2 (PFS2)(From the start of SABR treatment to the initiation of next-line treatment or death (an average of 3 year))