Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms
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: Cancer. Basic parameters: from 18 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
Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms
Overview
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.
Primary outcome measures
- Overall Survival [Time frame: Three years]
Secondary outcome measures (3)
- Progression Free Survival [Time frame: Three years]
- Overall Objective Response Rate [Time frame: At least 6 weeks after start of treatment]
- Percentage of Participants With Adverse Events [Time frame: Three years]
Eligibility 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.
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
- Fudan University Shanghai Cancer Center — Shanghai
Publications
- Dong H, Lan A, Gao J, An Y, Chu L, Yang X, Chu X, Hu J, Chu Q, Ni J, Zhu Z. Prognostic significance of bone metastasis and clinical value of bone radiotherapy in metastatic non-small cell lung cancer receiving PD-1/PD-L1 inhibitors: results from a multicenter, prospective, observational study. Transl Lung Cancer Res. 2024 Oct 31;13(10):2603-2616. doi: 10.21037/tlcr-24-441. Epub 2024 Oct 18. PMID 39507037
Identifiers
NCT: NCT04766515 · ARION