NCT07470840尚未招募2 期
A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years, regardless of sex.
- •Histologically or cytologically confirmed locally advanced/metastatic renal cell carcinoma (RCC) inoperable/refused for surgery, or post-operative locally recurrent/metastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.
- •ECOG performance status 0 or
- •At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).
- •No contraindications to radiotherapy, targeted therapy or immunotherapy.
- •At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Capable and willing to comply with the study protocol including scheduled visits, treatment plan, laboratory tests and other study-related procedures during the study period.
- •Signed written informed consent form.
排除标准
- •With contraindications to targeted or immunotherapeutic drugs.
- •A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.
- •With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.
- •Extensive diffuse metastasis with an expected survival of less than 3 months.
- •A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.
- •With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.
- •Allergic to any component of the study drugs.
- •The subject's baseline blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet ≥100×10⁹/L; ALT and AST ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <2 times the upper limit of normal.
研究组 & 干预措施
SBRT combined with Anlotinib and Bemarituzumab
Experimental
Interventions:
- Radiation: stereotactic body radiotherapy (SBRT)
- Drug: Anlotinib
- Drug: Bemarituzumab
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
SBRT combined with Anlotinib and Bemarituzumab
Experimental
Interventions:
- Radiation: stereotactic body radiotherapy (SBRT)
- Drug: Anlotinib
- Drug: Bemarituzumab
干预措施: Anlotinib (Drug)
SBRT combined with Anlotinib and Bemarituzumab
Experimental
Interventions:
- Radiation: stereotactic body radiotherapy (SBRT)
- Drug: Anlotinib
- Drug: Bemarituzumab
干预措施: Bemarituzumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.
次要结局
- Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1(Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.)
- Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0(From baseline through study treatment period, up to 2 years.)
- Disease Control Rate (DCR)(Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.)
- Overall Survival (OS)(Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.)
- Objective Response Rate in the Field of Irradiation(Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..)
- Progression-Free Survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
研究点 (1)
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