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Clinical Trials/NCT05862259
NCT05862259
Recruiting
Not Applicable

A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies

Xinqiao Hospital of Chongqing1 site in 1 country120 target enrollmentAugust 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Tumor
Sponsor
Xinqiao Hospital of Chongqing
Enrollment
120
Locations
1
Primary Endpoint
Progression-free survival
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy

Registry
clinicaltrials.gov
Start Date
August 10, 2023
End Date
December 31, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xinqiao Hospital of Chongqing
Responsible Party
Principal Investigator
Principal Investigator

Jianguo Sun

Deputy director of oncology department,clinical professor

Xinqiao Hospital of Chongqing

Eligibility Criteria

Inclusion Criteria

  • Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
  • the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.
  • the stage IV according to the eighth edition of IASLC.
  • PS 0-2, the expected survival \> 3 months.
  • the age of 18-75 years.
  • no contraindication to treatment with immune checkpoint inhibitors.

Exclusion Criteria

  • the patients' compliance was poor, which violated the rules of the trial;
  • the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
  • the patients with other malignant tumors;
  • the researchers considered that the patients should not participate in other conditions of the trial.

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: six months

The time between randomization and the first occurrence of disease progression or death from any cause

Secondary Outcomes

  • Objective response rate(one years)
  • Overall survival(two years)
  • Immune-Related Adverse Events(two years)

Study Sites (1)

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