Cancer
Conditions
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.
Interventions
None listed
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTZhengfei Zhu, MD
CONTACTJianjiao Ni, MD
PRINCIPAL_INVESTIGATORZhengfei Zhu, MD
Fudan University
STUDY_DIRECTORQian Chu, MD
Tongji Hospital
STUDY_DIRECTORJie Hu, MD
Shanghai Zhongshan Hospital
Outcome results
None listed