A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorXinqiao Hospital of Chongqing
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
receiving immunotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Progression-free survival
The time between randomization and the first occurrence of disease progression or death from any cause
Time frame
six monthsSecondary outcomes
1
Overall survival
Time from randomization to death from any cause
Time frame
two years2
Objective response rate
Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements
Time frame
one years3
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,
Time frame
two yearsOther outcomes
1
Indicators of cardiac injury
Including but not limited to troponin, BNP and cardiac magnetic resonance imaging
Time frame
two yearsSponsors and contacts
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Source ClinicalTrials.gov