A Clinical Study of Low-dose Radiotherapy Combined With Conventional Radiotherapy in Patients With Malignant Tumors After Immunotherapy Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Response was evaluated according to the Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) : ORR-To evaluate the objective effective rate of LDRT combined with SFRT and immunotherapy in patients with malignant tumors after immunotherapy resistance without standard regimens. PFS-To evaluate the progression-free survival (PFS) of patients with advanced malignant tumors after LDRT combined with SFRT and immunotherapy without standard regimens after immunotherapy resistance.DCR-To evaluate the proportion of patients with optimal response to LDRT and SFRT combined with immunotherapy to achieve complete response, partial response, or disease control after no standard regimen was available for immunotherapy resistance.HRQoL, AE and sAE-Evaluation of health related quality of life and safety of post-LDRT combined with SFRT and immunotherapy in patients with malignant tumors. To evaluate the benefit of patients in this trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient understood, participated voluntarily and signed the informed consent
- •Cytologically or histologically confirmed malignancy
- •Complete clinical data
- •The number of primary and regional metastatic lymph nodes and distant metastatic lesions was ≤10, and the number of organ metastases was ≤
- •Patients with malignant tumors who are resistant to immunotherapy (the patient's disease progression is evaluated after 6-8 weeks of treatment without improvement of clinical symptoms), and no standard treatment options are available.
- •Measurable primary lesions and regions
排除标准
- •Missing key patient data
- •Refusing or not cooperating with the study
- •Patients who have participated in other clinical studies/trials within 3 months
- •Patients with brain metastases
- •Patients with any conditions that the investigator judged to be ineligible for study participation
- •Patients with uncontrolled severe medical diseases who cannot tolerate radiotherapy
- •Past immune-related side effects (immune myocarditis, pneumonia, etc.)
- •Previous history of radiation therapy
研究组 & 干预措施
Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy failure
The chest, abdomen and pelvis were located by enhanced CT, and the target area was delineated. The lesions were visible lymph nodes with short diameter ≥1cm, and there were metastases confirmed by two associate chief physicians by enhanced MR and PET/CT examination results.
The primary lesion, the largest metastatic lesion or the lesion causing symptoms were selected and divided into 1.8-2Gy/F,40Gy-60Gy. For the remaining lesions, at least one easily evaluated and measurable lesion was selected as the observation lesion, and the unselected lesions (≤10 lesions) were given 1.6Gy/f, 1f/w, 4-6 times.
Immunotherapy regimens are administered according to the specific dose and interval of the original immunization regimen, such as concurrent chemotherapy or antiangiogenic drug therapy regimens. He used Nivolumab, Pembrolizumab, Troripalimab and Camrelizumanb.
Immunotherapy was performed at a frequency of 3 weeks in combination with radiotherapy until progression.
干预措施: At the same time, the original regimen of immunomaintenance therapy was continued, according to the frequency of the original immunization regimen once every 3 weeks until progress. (Radiation)
结局指标
主要结局
ORR
时间窗: Eighteen months
To evaluate the objective effective rate of LDRT combined with SFRT and immunotherapy in patients with malignant tumors after immunotherapy resistance without standard regimens.
次要结局
- DCR(Eighteen months)
- HRQoL、AE、SAE(Eighteen months)
- PFS(Eighteen months)
研究者
Jiandong Zhang
Chief physician
Qianfoshan Hospital