RecistTM criteria: RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Evaluation consistency — efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.
Trial sites (1)
Facility
City
Region
Status
Cancer Center, Dapping Hospital, Army Medical Center of PLA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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