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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 radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Group C | Experimental |
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| Group D | Experimental |
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| Group E | Experimental |
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| Group F | Experimental |
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| Group G | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patient must meet all of the following inclusion criteria to be enrolled in this study:
Exclusion Criteria:
Patients with any of the following criteria are not eligible for enrollment in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianguo Sun, MD | Contact | 023-68774490 | sunjg09@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Sun, MD | the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second affiliated hospital of Army medical university | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
|
|
| chemotherapy + PD-1 inhibitors | Drug | 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 becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
|
|
| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
|
|
| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
|
|
| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
|
|
| chemotherapy + PD-1 inhibitors | Drug | 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 intolerable. The maximum duration of immunotherapy shall not exceed 2 years. |
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| 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 |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000082082 | Immune Checkpoint Inhibitors |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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