Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

Cancer Clinical Trial

Official title:

Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766515
• Other study ID #: ARION
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2021
• Source: Fudan University
• Contact: Zhengfei Zhu, MD
• Phone: +86-18017312901
• Email: fuscczzf[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Three years
Secondary	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.	At least 6 weeks after start of treatment
Secondary	Percentage of Participants With Adverse Events	Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.	Three years