Lung Cancer Clinical Trial
— CINSBDRILCPOfficial title:
Dynamic Monitor of Serum Chromosomal Instability Detected by UCAD as a Surrogate Biomarker of Treatment Efficacy in PD1 Inhibitor Based Immunotherapy for Lung Cancer Patients
PD1, as an immune checkpoint inhibitor, has provided a new therapeutic approach for patients with cancer, including patients. Although immunotherapy has proven effective, most patients do not benefit from it because of a large proportion which developing primary and acquired resistance. However, there is still a lack of accurate and effective molecular biomarkers to accurately evaluate the drug resistance of patients treated with immune checkpoint inhibitors (ICI), so as to maximize the therapeutic effect in patients. Chromosomal instability (CIN) is one of the most prominent and common characteristics of solid tumors, accelerating the development of anti-cancer drug resistance, often leading to treatment failure and disease recurrence, which limits the effectiveness of most current treatments. Hence the aim of this study is to evaluate dynamic CIN continuously monitored in the blood of patients with lung cancer treated with ICIs with Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) to establish a new molecular immune resistance evaluation index. Further, the correlation between the evolution of tumor cloning and ICI resistance in patients during treatment was analyzed based on the results of dynamic CIN detection. This not only evaluate the efficacy of the ICI treatment in real-time, but also enables better understanding and overcoming the resistance mechanism of immunotherapy in the future.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 11, 2021 |
Est. primary completion date | November 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Stage IIIa-IVb Non-small-cell lung cancer patients without EGFR,ALK,ROS1,c-Met driven gene mutation. Male or female patients aged 20-70 years. - Patients planed to receive PD1 antibody treatment with or without chemotherapy, including as the neo-adjuvant therapy. - The subjects' age, sex, marital and reproductive history, collection time, pathology, cytology and imaging diagnosis were complete. - Participants signed informed consent form. Exclusion Criteria: - Eligible to target therapy with driven gene mutation. - Without measurable target lesion according to the RECIST criteria. - Age under 20 years or more than 70. - Individuals unwilling to sign the consent form or unwilling to provide PB for test or unwilling to provide the medical record. |
Country | Name | City | State |
---|---|---|---|
China | Di Zheng | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pulmonary Hospital, Shanghai, China |
China,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the concordance bettwen CINs and treatment outcomes The concordance between CINs and treatment outcomes | According to the correlation analysis between the patient's clinical drug resistance and CIN detected using UCAD, the stratified cutoff value interval of the patient was found, which was divided into four treatment outcomes based on CIN assessment : significant efficacy, primary drug resistance, acquired drug resistance and possible super progress. | through study completion, an average of 3 months | |
Secondary | the concordance bettwen CINs and clinical monitoring | Analyze the correlation between the dynamic change of CIN using UCAD and the efficacy evaluation by the RECIST criteria , and compare the time difference and accuracy between UCAD and imaging test and serology. | through study completion, an average of 3 months |
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