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临床试验 NCT06947694 针对无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases II期 427 免疫疗法 机器学习 生物标志物驱动
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临床试验NCT06947694旨在研究治疗，主要针对无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2025年7月2日，计划招募427名患者。该研究由Xinqiao Hospital of Chongqing主导，预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月22日。
简要概括
It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radioth...显示更多
官方标题
A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
疾病
无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)其他研究标识符
- XQonc-024
NCT编号
实际开始日期
2025-07-02
最近更新发布
2025-07-22
预计完成日期
2027-12-31
计划入组人数
427
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group A | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy \* 3-10 fractions) for pulmonary lesions, lymph node lesions and visceral lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity is intolera...显示更多 |
实验性Group B | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolera...显示更多 |
实验性Group C | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and bone metastatic lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity become...显示更多 |
实验性Group D | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity becomes intolerab...显示更多 |
实验性Group E | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and bone metastatic lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes ...显示更多 |
实验性Group F | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerab...显示更多 |
实验性Group G | chemotherapy + PD-1 inhibitors The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerab...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The remission rate of abscopal lesions | The remission rate of abscopal lesions. Immunotherapy is administered within less than 1 week after the start of radiotherapy. The time point for determining the abscopal effect is set as ≤ 4 cycles of immunotherapy. The assessment is carried out in accordance with the RECIST 1.1 (Appendix 1) and iPERCIST criteria. | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
PFS | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
OS | up to 5 years | |
ORR | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
DOR | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years | |
irAE | Adverse reactions related to immunotherapy | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years |
QoF | up to 2 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Non-small cell lung cancer diagnosed initially through pathological histology.
- There are 3-6 metastatic lesions.
- No brain metastasis or the lesions are stable.
- Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
- ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
- Aged between 18 and 75 years old.
- Evaluated by PET-CT (including FDG and FMISO, not mandatory).
- No contraindications for immunotherapy and radiotherapy.
- The informed consent form has been signed.
Patients with any of the following criteria are not eligible for enrollment in this study:
- Those with severe dysfunction of vital organs (heart, liver, kidney).
- Those accompanied by other malignant tumors.
- Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
- Those with a history of mental illness.
- And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
Xinqiao Hospital of Chongqing研究责任方
Jianguo Sun, 主要研究者, prof, Xinqiao Hospital of Chongqing
研究中心联系人
联系人: Jianguo Sun, MD, 023-68774490, [email protected]
1 位于 1 个国家/地区的研究中心
Chongqing Municipality
the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, 联系人, 023-68774490, [email protected]
招募中