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NCT Number: NCT05862259

A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies

In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy

Recruiting

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Key information

Conditions

Malignant Tumor Artificial Intelligence Immunotherapy Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

Location status: Recruiting

Location contact

jianguo sun, Phd

CONTACT

[email protected]

023-68774490

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
  • the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.
  • the stage IV according to the eighth edition of IASLC.
  • PS 0-2, the expected survival > 3 months.
  • the age of 18-75 years.
  • no contraindication to treatment with immune checkpoint inhibitors.

Exclusion criteria

  • the patients' compliance was poor, which violated the rules of the trial;
  • the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
  • the patients with other malignant tumors;
  • the researchers considered that the patients should not participate in other conditions of the trial.

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: six months

    The time between randomization and the first occurrence of disease progression or death from any cause

Secondary outcomes

  1. Overall survival

    Time frame: two years

    Time from randomization to death from any cause

  2. Objective response rate

    Time frame: one years

    Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements

  3. Immune-Related Adverse Events

    Time frame: two years

    In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,

Other outcomes

  1. Indicators of cardiac injury

    Time frame: two years

    Including but not limited to troponin, BNP and cardiac magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 17, 2023
Registry last updated
Jul 14, 2025

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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