MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC

Jiangsu Cancer Hospital

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Procedure: Operable

Study type: Observational

Funder types: Other

Identifiers

NCT06198868

2023K-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent must be signed before implementing any enrollment-related procedures;
2. Age ≥18 years old;
3. 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)；
4. There is no special restriction on the source of genetic test report.
5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
6. Have not received any previous systemic antitumor therapy for advanced diseases.
7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
8. ECOG score: 0-1;
9. Expected survival time > 3 months.

Exclusion criteria

1. Received surgical treatment for lung tumors.
2. Received neoadjuvant chemotherapy or radiotherapy.
3. Received cellular therapy within the last 1 year.
4. Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
5. Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.

Trial design

60 participants in 2 patient groups

Operable group

Description:

Early-stage patients with radical surgery or operable patients with neoadjuvant treatment

Treatment:

Procedure: Operable

Inoperable group

Description:

Advanced-stage patients receive non-surgery therapies.