Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
This prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (ICIs) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. This study aimed to assess the use, effectiveness, and safety of ICIs for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of ICIs for the treatment of cancer patients in the real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age at least 18 years.
Pathologically confirmed diagnosis of a solid tumor cancer.
Patients receiving treatment with immune checkpoint inhibitors.
Ability to understand and willingness to provide the informed consent.
Disqualifiers
Age < 18 years.
Patients with hematological malignancies or solid benign tumors.
Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Trial population
Adult patients with solid tumors treated with immune-checkpoints inhibitors
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
Overall Survival
OS was defined as the time from the date of first administration of immunotherapy until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Time frame
Three yearsSecondary outcomes
1
Progression Free Survival
PFS was measured from the date of first administration of immunotherapy to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.
Time frame
Three years2
Overall Objective Response Rate
ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame
At least 6 weeks after start of treatment3
Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Time frame
Three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov