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NCT Number: NCT04766515

Observational Prospective Study of Immune Checkpoint Inhibitors for Solid Neoplasms

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianjiao Ni, MD

CONTACT

[email protected]

13761974092

Zhengfei Zhu, MD

CONTACT

[email protected]

+86-18017312901

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Feb 23, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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