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Trial Title:
RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
NCT ID:
NCT06142058
Condition:
Evaluation
NSCLC
Targeted Therapy
Conditions: Keywords:
tumor marker
NSCLC
RECIST
RecistTM
positive driving gene
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
RecistTM criteria
Description:
RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted
therapy for NSCLC with positive driving gene.
Other name:
RECIST criteria
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.
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 clinical efficacy evaluation more objective and solves the problem of
consistency in clinical efficacy evaluation. 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 preliminary 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.
Investigators used statistical analysis to assess the consistency of efficacy evaluation
between the RecistTM criteria and the RECIST criteria, the correlation between different
efficacy and progression free survival (PFS) under the RecistTM, and the correlation
between the efficacy of RecistTM criteria and ctDNA level.
Criteria for eligibility:
Study pop:
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,
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Cancer Center, Dapping Hospital, Army Medical Center of PLA
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueqin Yang, PH.D.
Phone:
86-23-68757151
Email:
yangxueqin@hotmail.com
Investigator:
Last name:
Xueqin Yang, PH.D.
Email:
Principal Investigator
Start date:
November 13, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Xueqin Yang
Agency class:
Other
Source:
Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06142058
