NCT05719324

Brief Summary

This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

January 31, 2023

Last Update Submit

February 8, 2023

Conditions

Immunotherapy

Keywords

ImmunotherapyCheckpoint inhibitorSolid tumorPredictor

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS）

    PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.

    Up to 24 months.

Secondary Outcomes (1)

  • Overall survival (OS)

    Up to 24 months.

Other Outcomes (3)

  • Objective response rate (ORR)

    Up to 24 months.

  • Disease Control Rate (DCR)

    Up to 24 months.

  • Adverse events (AE)

    Up to 24 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.

You may qualify if:

  • Age ≥ 18 years old and gender is not limited.
  • Patients with unresectable solid tumors confirmed by pathology or histology.
  • Patients received checkpoint inhibitor therapy for 2 cycles or more.

You may not qualify if:

  • Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
  • Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
  • Pregnant or breastfeeding women.
  • Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Study Officials

  • Lingxiang Liu, MD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingxiang Liu, MD

CONTACT

(+86) 13851892074llxlau@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 8, 2023

Study Start

February 8, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

CN(1)