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

Recruiting

• Conditions: Malignant Tumor; Artificial Intelligence; Immunotherapy

• Registration Number: NCT05862259
• Lead Sponsor: Xinqiao Hospital of Chongqing

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Study Start: 2023-08-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-08-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	six months	The time between randomization and the first occurrence of disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Objective response rate	one years	Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements
Overall survival	two years	Time from randomization to death from any cause
Immune-Related Adverse Events	two years	In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,

Trial Locations

Locations (1)

the second affiliated hospital of Army medical university; 🇨🇳 Chongqing, Chongqing, China