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Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04766515
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Zhengfei Zhu, Fudan University

Study Description
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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.

Condition or disease
Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2025
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 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 :
  1. Progression Free Survival [ Time Frame: 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.

  2. Overall Objective Response Rate [ Time Frame: 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.

  3. Percentage of Participants With Adverse Events [ Time Frame: Three years ]
    Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with solid tumors treated with immune-checkpoints inhibitors
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766515


Contacts
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Contact: Zhengfei Zhu, MD +86-18017312901 fuscczzf@163.com
Contact: Jianjiao Ni, MD 13761974092 nijianjiao8@sina.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Zhengfei Zhu, MD    86-18017312901    fuscczzf@163.com   
Contact: Jianjiao Ni, MD    13761974092    nijianjiao8@sina.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Zhengfei Zhu, MD Fudan University
Study Director: Qian Chu, MD Tongji Hospital
Study Director: Jie Hu, MD Shanghai Zhongshan Hospital
More Information
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Responsible Party: Zhengfei Zhu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04766515    
Other Study ID Numbers: ARION
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms