NCT06142058 RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
| NCT ID | NCT06142058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xueqin Yang |
| Condition | Evaluation |
| Study Type | OBSERVATIONAL |
| Enrollment | 44 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 44 participants in total. It began in 2023-11-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06142058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Evaluation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06142058 currently recruiting?
Yes, NCT06142058 is actively recruiting participants. Contact the research team at yangxueqin@hotmail.com for enrollment information.
Where is the NCT06142058 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06142058 clinical trial?
NCT06142058 is sponsored by Xueqin Yang. The trial plans to enroll 44 participants.