NCT06142058Recruiting
RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
Source: ClinicalTrials.gov · Last updated 21 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 44 (estimated)
- First submitted
- 31 Oct 2023
- Start date
- 13 Nov 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Xueqin Yang
- Diseases
- Lung cancer
- NCT number
- NCT06142058
What you commit to
- Study type: Observational
- Planned participants: 44
- From 13 Nov 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to taking medication on time;
Other illness
- Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
Other
- Patients with dysphagia;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Center, Dapping Hospital, Army Medical Center of PLA Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.