Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Retrospective Study

NCT ID: NCT04397432

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

878 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-28

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Elemene, TKI, EGFR, Real world study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB\~IV).
2. Patients with EGFR mutation.
3. Received EGFR-TKIs at least once.
4. Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
5. Completeness of important outcome measures and medical records related to the study.

Exclusion Criteria

1. Accompanied by other active tumors.
2. The researchers did not consider it appropriate to participate in this study for other reasons.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Tian Xie

OTHER

Sponsor Role lead

Responsible Party

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Tian Xie

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ziping Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Panjin Central Hospital

Panjin, Liaoning, China

Site Status

Shenyang Tenth People's Hospital

Shenyang, Liaoning, China

Site Status

The Second People's Hospital of Yangcheng County

Jincheng, Shanxi, China

Site Status

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Site Status

Zhejiang Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Site Status

Hangzhouwan Hospital

Ningbo, Zhejiang, China

Site Status

Dongfang Hospital Beijing University of Chinese Medicine

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Cancer Hospital of Huanxing Chaoyang District Beijing

Beijing, , China

Site Status

Chongqing University Cancer Hospital

Chongqing, , China

Site Status

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Site Status

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Site Status

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, , China

Site Status

Tianjin Medical University General Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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HangzhouNU

Identifier Type: -

Identifier Source: org_study_id