Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

Recruiting

• Conditions: Cancer

• Registration Number: NCT04766515
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-20
• Last Update Submitted: 2021-02-20
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23
• Primary Completion: 2023-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Percentage of Participants With Adverse Events	Three years	Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China