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

• Conditions: Chemoradiotherapy; NSCLC; ctDNA

• Registration Number: NCT04741633
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-01-02
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-05
• Last Update Posted: 2021-02-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PFS	Six months after consolidation treatment
OS	Six months after consolidation treatment

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China