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

Immunotherapy Clinical Trial

Official title:

A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862259
• Other study ID #: XQonc-021
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: August 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Immunotherapy
• Malignant Tumor
• Neoplasms

Locations

Country	Name	City	State
China	the second affiliated hospital of Army medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Indicators of cardiac injury	Including but not limited to troponin, BNP and cardiac magnetic resonance imaging	two years
Primary	Progression-free survival	The time between randomization and the first occurrence of disease progression or death from any cause	six months
Secondary	Overall survival	Time from randomization to death from any cause	two years
Secondary	Objective response rate	Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements	one years
Secondary	Immune-Related Adverse Events	In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,	two years