Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Overall Survival [Three years]
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.
Secondary Outcome Measures
- Progression Free Survival [Three years]
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.
- Overall Objective Response Rate [At least 6 weeks after start of treatment]
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.
- Percentage of Participants With Adverse Events [Three years]
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | China |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Zhengfei Zhu, MD, Fudan University
- Study Director: Qian Chu, MD, Tongji Hospital
- Study Director: Jie Hu, MD, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARION