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Trial Title:
A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies
NCT ID:
NCT05862259
Condition:
Malignant Tumor
Immunotherapy
Artificial Intelligence
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
receiving immunotherapy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. 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.
2. the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma,
stomach, breast, urinary system, etc.) were diagnosed by histopathology.
3. the stage IV according to the eighth edition of IASLC.
4. PS 0-2, the expected survival > 3 months.
5. the age of 18-75 years.
6. no contraindication to treatment with immune checkpoint inhibitors.
Exclusion Criteria:
1. the patients' compliance was poor, which violated the rules of the trial;
2. the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
3. the patients with other malignant tumors;
4. the researchers considered that the patients should not participate in other
conditions of the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the second affiliated hospital of Army medical university
Address:
City:
Chongqing
Zip:
40037
Country:
China
Status:
Recruiting
Contact:
Last name:
jianguo sun, Phd
Phone:
023-68774490
Email:
sunjg09@aliyun.com
Start date:
August 10, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Xinqiao Hospital of Chongqing
Agency class:
Other
Source:
Xinqiao Hospital of Chongqing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862259
