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
Investigators
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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