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RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

NCT ID: NCT06142058

Last Updated: 2023-11-21

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

RECRUITING

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-13

Study Completion Date

2028-12-31

Brief Summary

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Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.

Detailed Description

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Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.

Conditions

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Evaluation NSCLC Targeted Therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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RecistTM criteria

RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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RECIST criteria

Eligibility Criteria

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Inclusion Criteria

* NSCLC patients with stage IIIB-IV
* Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);
* First line targeted therapy.
* Performance status of 0-2 on the ECOG criteria.
* Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA\>15ng/ml,CA-199\>105U/ml,CA-125\>105 U/ml, NSE\>60 ng/ml, SCCAg\>7.5 ng/ml, CYFRA21-1\>21 ng/ml, et al.
* Measurable lesions present
* Age\>=18
* Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 60,000/uL,hemoglobin≥70g/L), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function.
* Informed consent from patient or patient's relative.

Exclusion Criteria

* Patients with dysphagia;
* Unable to taking medication on time;
* Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xueqin Yang

OTHER

Sponsor Role lead

Responsible Party

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Xueqin Yang

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cancer Center, Dapping Hospital, Army Medical Center of PLA

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xueqin Yang, PhD

Role: CONTACT

[email protected]
15923366936

Facility Contacts

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Xueqin Yang, PH.D.

Role: primary

[email protected]
86-23-68757151

Other Identifiers

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RecistTM-1

Identifier Type: -

Identifier Source: org_study_id