A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant Tumor, Immunotherapy, Artificial Intelligence. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Primary outcome measures
- Progression-free survival [Time frame: six months]
Secondary outcome measures (3)
- Overall survival [Time frame: two years]
- Objective response rate [Time frame: one years]
- Immune-Related Adverse Events [Time frame: two years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- the second affiliated hospital of Army medical university — Chongqing
Identifiers
NCT: NCT05862259 · XQonc-021