A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies

NCT ID: NCT05862259

Last Updated: 2025-07-14

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

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Malignant Tumor Immunotherapy Artificial Intelligence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

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Jianguo Sun

Deputy director of oncology department,clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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jianguo sun, Phd

Role: primary

023-68774490

Other Identifiers

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XQonc-021

Identifier Type: -

Identifier Source: org_study_id

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