Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy

Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04741633

Acronym

NSCLC

Enrollment

Registered

2021-02-05

Start date

2020-04-01

Completion date

2022-12-31

Last updated

2021-02-05

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

Conditions

Chemoradiotherapy, ctDNA, NSCLC

Brief summary

The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Non small cell lung cancer patients confirmed by pathology; 2. They were 18-80 years old; 3. The tumor could not be resected or could not tolerate surgery; 4. Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy; 5. Clinical stage III (AJCC, 8th Edition, 2017); 6. After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc; 7. Patient informed consent.

Exclusion criteria

1. After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out 2. It can not cooperate with the completion of baseline mutation screening and subsequent sample detection 3. Factors judged by other researchers not suitable for further study

Design outcomes

Primary

Measure	Time frame	Description
Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy	Six months after consolidation treatment	The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process

Secondary

Measure	Time frame
PFS	Six months after consolidation treatment
OS	Six months after consolidation treatment

Countries

China

Outcome results