Status:
RECRUITING
RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
Lead Sponsor:
Xueqin Yang
Conditions:
Evaluation
NSCLC
Eligibility:
All Genders
18+ years
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 dri...
Detailed Description
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06142058
Start Date
November 13 2023
End Date
December 31 2028
Last Update
November 21 2023
Active Locations (1)
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1
Cancer Center, Dapping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality, China, 400042