RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

Recruiting now

Conditions studied: Evaluation, NSCLC, Targeted Therapy

In brief

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.

Key facts

Study ID

NCT06142058

Run by

Xueqin Yang

People needed

44

Starts

2023-11-13

Expected to finish

2028-12-31

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cancer Center, Dapping Hospital, Army Medical Center of PLA — Chongqing, Chongqing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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