Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 主要终点
- Progression free survival 2, PFS2
研究概览
简要总结
Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies our team has shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, we aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.
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
- •Age ≥ 18 years old
- •Histologically or cytologically confirmed clear cell renal cell carcinoma
- •Eligible for radiation therapy: no more than 10 lesions in total
- •Expected survival: over 3 months
- •ECOG: 0 or 1
- •Sufficient organ function
- •Written informed consent
排除标准
- •Brain metastasis/carcinomatous meningitis
- •Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer.
- •Pregnant or breastfeeding.
- •Active infection.
研究组 & 干预措施
NY104 and FDG guided RT combining systemic therapy
In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.
干预措施: 68Ga-NY104 PET/CT (Drug)
NY104 and FDG guided RT combining systemic therapy
In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.
干预措施: 18F-FDG PET/CT (Drug)
NY104 and FDG guided RT combining systemic therapy
In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.
干预措施: Radiation Therapy (Radiation)
NY104 and FDG guided RT combining systemic therapy
In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.
干预措施: Systemic therapy (Drug)
结局指标
主要结局
Progression free survival 2, PFS2
时间窗: the time from the start of RT to 4 years after treatment
Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed.
次要结局
- Lesion uptake on 68Ga-NY104 PET/CT(From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT)
- Lesion uptake on 18F-FDG PET/CT(From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT)
- Number of positive lesions detected on 68Ga-NY104 PET/CT(From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT)
- Number of positive lesions detected on 18F-FDG PET/CT(From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT)
- Number of lesions detected combining all available imaging modalities(From the start of any imaging modality to 1 week after completion of all imaging modalities)
- Objective response rate(the time from the start of RT to 4 years after treatment)
- Progression free survival 1, PFS1(the time from the start of RT to 4 years after treatment)
- Disease control rate(the time from the start of RT to 4 years after treatment)
- Overall survival(the time from the start of RT to 4 years after treatment)
- Adverse event(the time from the start of RT to 4 years after treatment)