Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Jiangsu Cancer Institute & Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the Progression-free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.
Detailed Description
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.
Investigators
Rong Yin, MD PhD
Professor
Jiangsu Cancer Institute & Hospital
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be signed before implementing any enrollment-related procedures;
- •Age ≥18 years old;
- •Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
- •There is no special restriction on the source of genetic test report.
- •According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
- •Have not received any previous systemic antitumor therapy for advanced diseases.
- •No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
- •ECOG score: 0-1;
- •Expected survival time \> 3 months.
Exclusion Criteria
- •Received surgical treatment for lung tumors.
- •Received neoadjuvant chemotherapy or radiotherapy.
- •Received cellular therapy within the last 1 year.
- •Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
- •Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
Outcomes
Primary Outcomes
To evaluate the Progression-free Survival (PFS)
Time Frame: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years
Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.
Secondary Outcomes
- To evaluate the Overall Survival (OS)(From the date of first dose of study drug until date of death from any cause (up to approximately 5 years ))