RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXueqin Yang
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
NSCLC patients with stage IIIB-IV，Driver gene positive， and any one of the tumor markers is more than three times higher than the normal level,
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
RecistTM criteria
Diagnostic testRecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluation consistency
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.
Time frame
efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 yearSecondary outcomes
1
progression-free survival （PFS）
The correlation between the efficacy evaluation results of the RecistTM criteria and the RECIST criteria and PFS
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsOther outcomes
1
The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing
The correlation between the efficacy evaluated by the RecistTM criteria and the ctDNA amounts detected by NGS
Time frame
At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xueqin Yang
Lead sponsor
Third Military Medical University
Sponsor institution
Source ClinicalTrials.gov