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| Name | Class |
|---|---|
| LinkDoc Technology (Beijing) Co. Ltd. | INDUSTRY |
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This is a nationwide, multicenter and retrospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of serious adverse events. However, after a median of 8 to 13 months of disease control, patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown to have a comprehensive anti-tumor effect and the potential effect on reversing drug resistance.
The study is a real-world study and the case records of patients with advanced non-small cell lung cancer who visited the research centers from January 2014 to December 2017 and met the inclusion criteria will be collected. Medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elemene plus TKIs | This is a real-world study, we just record the patient's medication who used Elemene Injectable Emulsion and/or Elemene Oral Emulsion plus TKIs. First, second or third generation TKIs were all available, such as Erlotinib, Gefitinib, Icotinib, Afatinib, Dacomitinib, and Osimertinib. | ||
| TKIs only | This is a real-world study, we just record the patient's medication who used TKIs only. First, second or third generation TKIs were all available, such as Erlotinib, Gefitinib, Icotinib, Afatinib, Dacomitinib, and Osimertinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| OS | OS was defined as the interval from the date of the administration of the first-dose TKIs to date of death from any cause, or the date of last known follow-up alive. | June 2021 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was defined as the interval from date of the administration of the first-dose TKIs to the date of first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1. | June 2021 |
| ORR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced non-small cell lung cancer and EGFR mutation who visited the research centers from January 2014 to December 2017 and received TKIs therapy with or without Elemene.
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| Name | Affiliation | Role |
|---|---|---|
| Ziping Wang, PhD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | China | |||
| Panjin Central Hospital |
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ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1. |
| June 2021 |
| DCR | Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1. | June 2021 |
| KPS score | Performance status were measured by Karnofsky Performance Scale (KPS). | June 2021 |
| ECOG score | Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard. | June 2021 |
| Incidence and severity of AE or SAE | Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | Start of treatment until 30 days after the last dose. |
| Panjin |
| Liaoning |
| China |
| Shenyang Tenth People's Hospital | Shenyang | Liaoning | 110000 | China |
| The Second People's Hospital of Yangcheng County | Jincheng | Shanxi | China |
| Sichuan Academy of Medical Sciences ยท Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Hangzhou Cancer Hospital | Hangzhou | Zhejiang | China |
| Tongde Hospital of Zhejiang Province | Hangzhou | Zhejiang | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | China |
| Zhejiang Xiaoshan Hospital | Hangzhou | Zhejiang | China |
| Hangzhouwan Hospital | Ningbo | Zhejiang | China |
| Dongfang Hospital Beijing University of Chinese Medicine | Beijing | 100078 | China |
| Beijing Cancer Hospital | Beijing | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |
| Cancer Hospital of Huanxing Chaoyang District Beijing | Beijing | China |
| Chongqing University Cancer Hospital | Chongqing | China |
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | China |
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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