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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Tianjin Medical University | OTHER |
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The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with Perilesional edema in non-small cell lung cancer.
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with perilesional edema in non-small cell lung cancer. The sample size is 50. Patients start to take Anlotinib 1 week before the MRI-based simulation,12mg/d QD,day1~14, day22~36.Edema index will be used to evaluate the effectiveness of Anlotinib. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRS Combination With Anlotinib | Experimental | Stereotactic Radiosurgery Combination With Anlotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EI | Edema Index. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free Survival | 1 year |
| OS | Overall Survival | 1 year |
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Inclusion Criteria:
Patients voluntarily participate in this study, signed informed consent.
Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
Patients aged between 18 -80 years; with expected survival time>3 months.
Patients with no more than 5 brain metastases
Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
a) blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
Female patients should agree to use contraceptives during and within 6 months after the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongqing Zhuang, doctor | Contact | 13051776232 | hongqingzhuang@163.com | |
| Yuxia Wang, doctor | Contact | 15001292991 | lily31415926@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongqing Zhuang, doctor | Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist. | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33294918 | Derived | Zhuang H, Wang Y, Cheng C, Shi S. The efficacy of anlotinib instead of glucocorticoids for edema induced by brain metastases in NSCLC patients with anti-PD1/PDL-1 immunotherapy. Neuro Oncol. 2021 Jan 30;23(1):169-171. doi: 10.1093/neuonc/noaa236. No abstract available. |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D020533 | Angiogenesis Inhibitors |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| Stereotactic Radiosurgery | Radiation | Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases |
|
| ORR |
Objective Response Rate |
| 3 months |
| DCR | Disease Control Rate | 3 months |
| iORR | intracranial objective response rate | 3 months |
| iPFS | intracranial progression-free survival | 3 months |
| SRS rate | the rate of SRS after anlotinib treatment | 1 month |
|
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |