RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
Xueqin Yang
44 participants
Nov 13, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria3
- 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
Interventions
RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06142058