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

NCT05862259 | Recruiting

• 1 other identifier: XQonc-021
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Tumor; Immunotherapy; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  six months

Secondary Outcomes (3)

• Overall survival

  two years

• Objective response rate

  one years

• Immune-Related Adverse Events

  two years

Other Outcomes (1)

• Indicators of cardiac injury

  two years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

receiving immunotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of oncology department，clinical professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: August 10, 2023
• Primary Completion: August 10, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)