- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397432
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Retrospective Study (SELECT-1)
Synergistic Real-world Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors(TKIs)in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC):Retrospective Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Tian Xie, PhD
- Phone Number: +86-13606707928
- Email: xbs@dljg.sina.net
Study Contact Backup
- Name: Xinbing Sui, PhD
- Phone Number: +86-13486192868
- Email: hzzju@zju.edu.cn
Study Locations
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Beijing, China
- Beijing Cancer Hospital
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Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, China, 100078
- Dongfang Hospital Beijing University of Chinese Medicine
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Beijing, China
- Cancer Hospital of Huanxing Chaoyang District Beijing
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Chongqing, China
- Chongqing University Cancer Hospital
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Shanghai, China
- Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
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Shanghai, China
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
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Tianjin, China
- Tianjin Medical University General Hospital
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Tianjin, China
- Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
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Jiangsu
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Nantong, Jiangsu, China
- Affiliated Hospital of Nantong University
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Liaoning
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Panjin, Liaoning, China
- Panjin Central Hospital
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Shenyang, Liaoning, China, 110000
- Shenyang Tenth People's Hospital
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Shanxi
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Jincheng, Shanxi, China
- The Second People's Hospital of Yangcheng County
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Sichuan
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Chendu, Sichuan, China
- Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
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Zhejiang
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Hangzhou, Zhejiang, China
- Zhejiang Hospital
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Hangzhou, Zhejiang, China
- Zhejiang Xiaoshan Hospital
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Hangzhou, Zhejiang, China
- Hangzhou Cancer Hospital
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Hangzhou, Zhejiang, China
- Tongde Hospital of Zhejiang Province
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Ningbo, Zhejiang, China
- Hangzhouwan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB~IV).
- Patients with EGFR mutation.
- Received EGFR-TKIs at least once.
- Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
- Completeness of important outcome measures and medical records related to the study.
Exclusion Criteria:
- Accompanied by other active tumors.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: June 2021
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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.
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June 2021
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: June 2021
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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.
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June 2021
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ORR
Time Frame: June 2021
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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.
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June 2021
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DCR
Time Frame: June 2021
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Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
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June 2021
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KPS score
Time Frame: June 2021
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Performance status were measured by Karnofsky Performance Scale (KPS).
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June 2021
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ECOG score
Time Frame: June 2021
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Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.
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June 2021
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Incidence and severity of AE or SAE
Time Frame: Start of treatment until 30 days after the last dose.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ziping Wang, PhD, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HangzhouNU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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