ImmunotherapyNCT05719324
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
An observational study of Immunotherapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2022to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.
Who may be able to join
- Age ≥ 18 years old and gender is not limited.
- Patients with unresectable solid tumors confirmed by pathology or histology.
- Patients received checkpoint inhibitor therapy for 2 cycles or more.
Who cannot join
- Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
- Pregnant or breastfeeding women.
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
- The investigator judges that other conditions are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Lingxiang Liu, MD, (+86) 13851892074, llxlau@163.com
About this study
This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.
Read the detailed description
The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.
- Conditions
- Immunotherapy
- Keywords
- Immunotherapy, Checkpoint inhibitor, Solid tumor, Predictor
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS）
PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.
Measured: Up to 24 months.
Secondary outcomes (1)
Overall survival (OS)
OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up.
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Feb 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingxiang Liu, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719324
- Sponsor's protocol ID
- 2022-SR-219
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study
- ClinicalTrials.gov ID
- NCT05719324
- Acronym / sponsor ID
- 2022-SR-219
- Conditions
- Immunotherapy
- Keywords
- Immunotherapy, Checkpoint inhibitor, Solid tumor, Predictor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.
Detailed description
The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable solid tumors confirmed by histopathology or cytology, and continuously treated with checkpoint inhibitor based treatment for 2 cycles or more.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old and gender is not limited.
- Patients with unresectable solid tumors confirmed by pathology or histology.
- Patients received checkpoint inhibitor therapy for 2 cycles or more.
Key exclusion criteria (5 listed)
- Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment.
- Pregnant or breastfeeding women.
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
- The investigator judges that other conditions are not suitable for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS）
Time frame: Up to 24 months.
PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.
1 secondary outcome
Overall survival (OS)
Time frame: Up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingxiang Liu, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunotherapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingxiang Liu, MD ((+86) 13851892074, llxlau@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS） (time frame: Up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.