Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms
Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms
1 other identifier
observational
6,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
ExpectedJune 30, 2026
June 1, 2026
3 years
February 20, 2021
June 28, 2026
Conditions
Outcome Measures
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.
Three years
Secondary Outcomes (3)
Progression Free Survival
Three years
Overall Objective Response Rate
At least 6 weeks after start of treatment
Percentage of Participants With Adverse Events
Three years
Eligibility Criteria
Adult patients with solid tumors treated with immune-checkpoints inhibitors
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, China
Related Publications (1)
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: 39507037DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Zhengfei Zhu, MD
Fudan University
- STUDY DIRECTOR
Qian Chu, MD
Tongji Hospital
- STUDY DIRECTOR
Jie Hu, MD
Shanghai Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2021
First Posted
February 23, 2021
Study Start
September 1, 2020
Primary Completion
August 31, 2023
Study Completion (Estimated)
August 30, 2027
Last Updated
June 30, 2026
Record last verified: 2026-06