RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

NCT06142058 | Recruiting

• 1 other identifier: RecistTM-1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaluation; NSCLC; Targeted Therapy

Keywords

tumor marker; NSCLC; RECIST; RecistTM; positive driving gene

Outcome Measures

Primary Outcomes (1)

• Evaluation consistency

  The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.

  efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year

Secondary Outcomes (1)

• progression-free survival （PFS）

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Other Outcomes (1)

• The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing

  At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 years

Interventions

RecistTM criteria DIAGNOSTIC_TEST

RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.

Also known as: RECIST criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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,

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

Sponsors & Collaborators

• Xueqin Yang: lead

Study Sites (1)

Cancer Center, Dapping Hospital, Army Medical Center of PLA

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patient ctDNA samples are used for NGS detections, with each patient planning to take blood 3-4 times。

MeSH Terms

Interventions

Response Evaluation Criteria in Solid Tumors

Intervention Hierarchy (Ancestors)

Treatment Outcome; Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Central Study Contacts

Xueqin Yang, PhD

CONTACT

15923366936; yangxueqin@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 21, 2023
• Study Start: November 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

CN (1)