RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

Launched by XUEQIN YANG · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a specific set of criteria, called RecistTM, can evaluate the effectiveness of targeted therapy in patients with advanced non-small cell lung cancer (NSCLC) who have certain gene mutations known as "driver genes." These driver genes can make tumors behave differently, and the researchers believe that using the RecistTM criteria may help them better understand how well the treatment is working for these patients. The trial aims to improve these evaluation rules and confirm their reliability.

To participate in this study, patients must have stage IIIB-IV NSCLC, be positive for specific driver genes (like EGFR or ALK), and be starting their first targeted therapy. They should also be between 18 and 75 years old and have measurable tumors. Participants will undergo evaluations to see how their tumors respond to the therapy, and they will need to provide informed consent. It's important to note that patients with swallowing difficulties or certain mental health issues will not be eligible for this trial.

Gender

ALL

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