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A multicenter, prospective, observational clinical study of ctDNA monitoring the risk of progression after first-line long-term immunotherapy in patients with advanced NSCLC

A multicenter, prospective, observational clinical study of ctDNA monitoring the risk of progression after first-line long-term immunotherapy in patients with advanced NSCLC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055132
Enrollment
Unknown
Registered
2022-01-01
Start date
2021-12-30
Completion date
Unknown
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

case series:None

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Advanced non-small cell lung cancer (IIIB-IV stage), pathological type limited to squamous cell carcinoma or adenocarcinoma (no EGFR/ALK/ros1 gene mutation); 3. General condition: ECOG score 0 or 1; 4. Receive first-line immune checkpoint inhibitor monotherapy or combination therapy; 5. Sustained benefit of immunotherapy, defined in this study as PFS >= 1 year (the efficacy evaluation is CR/PR/SD); 6. Tumor tissue samples are available at the time of enrollment, and at least 5-10 sections can be generated, and the pathology report indicates that the total tumor content is not less than 10%; 7. There is at least one measurable lesion (except for patients with CR after first-line treatment), which can be evaluated according to RECIST1.1 criteria; 8. Have self-awareness, be able to understand the research plan and voluntarily participate in this research, and can sign the informed consent; 9. Good compliance, able to cooperate with the collection of specimens from each node and provide corresponding clinical information.

Exclusion criteria

Exclusion criteria: 1. Serious primary diseases of the heart, liver, kidney, hematopoietic system, etc.; 2. Suffering from other malignant tumors within 3 years before the diagnosis of NSCLC; 3. Pregnant and lactating patients; 4. Active period of human immunodeficiency virus (HIV) infection; 5. Those with active systemic infection, pneumonia, tuberculosis, and pericarditis; 6. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Lead time;Overall survival;

Countries

China

Contacts

Public ContactWu Fang

The Second Xiangya Hospital of Central South University

doctor_wufang@126.com+86 13574858332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026