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

NCT04741633 | Unknown

• 1 other identifier: CID-001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; Chemoradiotherapy; ctDNA

Outcome Measures

Primary Outcomes (1)

• Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy

  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

  Six months after consolidation treatment

Secondary Outcomes (2)

• PFS

  Six months after consolidation treatment

• OS

  Six months after consolidation treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and subsequent immunoconsolidation therapy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: February 5, 2021
• Study Start: April 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

CN (1)