Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients

NCT ID: NCT05688046

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

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Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.

Detailed Description

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The investigators reviewed the medical records of all lung cancer patients in the Cancer Diagnosis and Treatment Center of Suzhou Hospital Affiliated to Nanjing Medical University from January 1, 2019 to December 31, 2021, and a total of 79 patients were enrolled. The subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(IA group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(NIA group). The data of PFS, OS, ORR, covariates, and Immune-related adverse events (irAEs) were collected through electronic medical records and follow-up. The primary endpoint of the study was PFS, and the secondary endpoints were OS, ORR and irAEs.All enrolled patients were followed up until August 1, 2022.

Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IA group

Immune checkpoint inhibitors plus angiogenesis inhibitors group

Immune checkpoint inhibitors plus angiogenesis inhibitors

Intervention Type DRUG

PD-(L)1-based therapy plus Bevacizumab or Anlotinib

NIA group

Immune checkpoint inhibitors without angiogenesis inhibitors group

Immune checkpoint inhibitors without angiogenesis inhibitors

Intervention Type DRUG

PD-(L)1-based therapy

Interventions

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Immune checkpoint inhibitors plus angiogenesis inhibitors

PD-(L)1-based therapy plus Bevacizumab or Anlotinib

Intervention Type DRUG

Immune checkpoint inhibitors without angiogenesis inhibitors

PD-(L)1-based therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥65 years old.
2. Stage IV according to the AJCC Cancer grading manual (8th edition).
3. Histologically confirmed NSCLC.
4. No driver mutations.
5. Received at least 2 courses of immunotherapy.
6. Expected survival time \> 3 months.
7. No concurrent malignancy.
8. Not participating in a clinical trial.
9. The functions of important organs were basically normal.
10. Sign informed consent.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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jing xue

Associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Xue

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Suzhou Hospital of Nanjing Medical University

Locations

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The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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IMAGINE

Identifier Type: -

Identifier Source: org_study_id

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