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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05862259

Enrollment

120

Registered

2023-05-17

Start date

2023-08-10

Completion date

2025-12-31

Last updated

2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Immunotherapy, Malignant Tumor

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall survival	two years	Time from randomization to death from any cause
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
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

Measure	Time frame	Description
Indicators of cardiac injury	two years	Including but not limited to troponin, BNP and cardiac magnetic resonance imaging

Countries

China

Outcome results