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

• Sponsor: Xinqiao Hospital of Chongqing (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05862259
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 31.7
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Tumor; Immunotherapy; Artificial Intelligence

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: May 10, 2023
• Anticipated Primary Completion Date: May 10, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [six months]

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

Secondary Outcome Measures

1. Overall survival [two years]

   Time from randomization to death from any cause

2. 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

3. 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,

Other Outcome Measures

1. Indicators of cardiac injury [two years]

   Including but not limited to troponin, BNP and cardiac magnetic resonance imaging

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the second affiliated hospital of Army medical university	Chongqing	Chongqing	China	40037

Sponsors and Collaborators

• Xinqiao Hospital of Chongqing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianguo Sun, Deputy director of oncology department，clinical professor, Xinqiao Hospital of Chongqing
• ClinicalTrials.gov Identifier: NCT05862259
• Other Study ID Numbers: XQonc-021
• First Posted: May 17, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of May 18, 2023