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This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort A | Active Comparator | Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy |
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| cohort B | Experimental | Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total |
|
| cohort C | Experimental | Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | Different cohorts received different doses of radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial progression-free survival | assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI | up to 2 years from enrollment |
| sPFS | assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI | up to 2 years from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate | assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI | up to 2 years from enrollment |
| overall survival | the time from enrollment until death or the last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang C Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong C Yang, MD | Contact | +8613873123436 | +8613873123436 | yangnong0217@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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| Chemotherapy + immunotherapy | Drug | Chemotherapy + immunotherapy |
|
| up to 2 years from enrollment |
| number of participants with treatment-related adverse events | number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 2 years from enrollment |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |