Malignant NeoplasmNCT05754983
Risk Factors and Long-term Impact of ICIs
An observational study of Malignant Neoplasm, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse events and health status to build a disease cohort database based on patient reports, and then analyze the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Solid tumor patients receiving immunotherapy for the first time were included in the study
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2022to 31 Dec 2025
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: The included population is malignant solid tumor patients receiving immunotherapy for the first time
Who may be able to join
- Age range of subjects: the age of subjects is no less than 18 years old;
- Receiving any ICIs treatment or ICIs combined with other treatments;
- Soild malignant tumor proved by pathology (histology or cytology);
- First treatment with ICIs {including ICIs (first) combined with other treatments)};
- Any stage and treatment line (new auxiliary, auxiliary and advanced treatment)
- Willing to treat, and can come to the hospital regularly in the later period
Who cannot join
- Previous medical history of other malignant tumors;
- No pathology (histology or cytology) certificate;
- Having received ICIs or other immunotherapy in the past;
- Participated in clinical research in the past and may have applied ICIs or other immunotherapy;
- Weak treatment intention or long-term treatment in other hospitals/departments
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospitap of Xian Jiaotong University
Xi’an, Shanxi, 710061
About this study
Official title: To Evaluate the Prognostic Risk Factors and Long-term Health Effects of Immunotherapy Patients Based on the Specific Disease Cohort Registered With Patients
This study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse events and health status to build a disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients
Read the detailed description
This study is intended to conduct a multicenter, observable and controlled cohort study in multiple clinical centers including the First Affiliated Hospital of Xi'an Jiaotong University to solid-tumor patients who received immunotherapy for the first time. The baseline information before treatment was collected (mainly including three collection methods, namely, patients' self filling information, physician assisted filling information, and medical record system import information. The information collected was mainly in the following aspects: demographic characteristics, tumor and anti-tumor information, gene testing information, blood sample collection information, and questionnaire evaluation information) and follow-up information after treatment (The collection method and content are the same as the baseline information.) Collect the relevant factors that may affect the treatment efficacy and prognosis of patients, build a prospective disease cohort database based on patient reports, and then analyze the risk factors that affect the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. We also retrospectively collected some data from medicine records for validation. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS), objective response rate (ORR), immune-related adverse events (irAEs) and the scoring results of various questionnaires (PHQ-9, etc). It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients.
- Conditions
- Malignant Neoplasm
- Being tested
- Solid tumor patients receiving immunotherapy for the first time were included in the study
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid tumor patients receiving immunotherapy for the first time were included in the studyDrug
Solid tumor patients receiving immunotherapy were included in the study. Baseline information before treatment (including demographic characteristics, basic diseases and their medication history, tumor and anti-tumor history, quality of life scores, etc.) and follow-up information after treatment (PFS, OS, etc.) were collected to summarize factors that may affect the efficacy and prognosis of patients receiving immunotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival (PFS)
It refers to the time from randomization to disease progression
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start24 Nov 2022
- Primary completion30 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754983
- Sponsor's protocol ID
- XJTU1AF2022LSL-020
- Status last verified
- Aug 2024
- First submitted
- 10 Jan 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Jia X, Liu M, Zhu Z, Qiao H, Jiang J, Li M, Xia W, Xu L, Zhang E, Wang W, Liu J, Xu R, Qi Y, Jing G, Bai Y, Jiao M, Hu S, Liu Z, Guo H, Jiang L. Impact of NSAID type, initiation timing, duration and dose on clinical outcomes of immunotherapy in NSCLC: a multicenter two-cohort study. J Immunother Cancer. 2026 Apr 1;14(4):e014360. doi: 10.1136/jitc-2025-014360.
PubMed 41922087
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Prognostic Risk Factors and Long-term Health Effects of Immunotherapy Patients Based on the Specific Disease Cohort Registered With Patients
- ClinicalTrials.gov ID
- NCT05754983
- Acronym / sponsor ID
- XJTU1AF2022LSL-020
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 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 study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse events and health status to build a disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients
Detailed description
This study is intended to conduct a multicenter, observable and controlled cohort study in multiple clinical centers including the First Affiliated Hospital of Xi'an Jiaotong University to solid-tumor patients who received immunotherapy for the first time. The baseline information before treatment was collected (mainly including three collection methods, namely, patients' self filling information, physician assisted filling information, and medical record system import information. The information collected was mainly in the following aspects: demographic characteristics, tumor and anti-tumor information, gene testing information, blood sample collection information, and questionnaire evaluation information) and follow-up information after treatment (The collection method and content are the same as the baseline information.) Collect the relevant factors that may affect the treatment efficacy and prognosis of patients, build a prospective disease cohort database based on patient reports, and then analyze the risk factors that affect the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. We also retrospectively collected some data from medicine records for validation. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS), objective response rate (ORR), immune-related adverse events (irAEs) and the scoring results of various questionnaires (PHQ-9, etc). It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The included population is malignant solid tumor patients receiving immunotherapy for the first time
Key inclusion criteria (6 listed)
- Age range of subjects: the age of subjects is no less than 18 years old;
- Receiving any ICIs treatment or ICIs combined with other treatments;
- Soild malignant tumor proved by pathology (histology or cytology);
- First treatment with ICIs {including ICIs (first) combined with other treatments)};
- Any stage and treatment line (new auxiliary, auxiliary and advanced treatment)
Key exclusion criteria (5 listed)
- Previous medical history of other malignant tumors;
- No pathology (histology or cytology) certificate;
- Having received ICIs or other immunotherapy in the past;
- Participated in clinical research in the past and may have applied ICIs or other immunotherapy;
- Weak treatment intention or long-term treatment in other hospitals/departments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid tumor patients receiving immunotherapy for the first time were included in the studySolid tumor patients receiving immunotherapy were included in the study. Baseline information before treatment (including demographic characteristics, basic diseases and their medication history, tumor and anti-tumor history, quality of life scores, etc.) and follow-up information after treatment (PFS, OS, etc.) were collected to summarize factors that may affect the efficacy and prognosis of patients receiving immunotherapy | Drug | – |
Primary outcome
Progression-Free-Survival (PFS)
Time frame: Two years
It refers to the time from randomization to disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 41922087Li Y, Jia X, Liu M, Zhu Z, Qiao H, Jiang J, Li M, Xia W, Xu L, Zhang E, Wang W, Liu J, Xu R, Qi Y, Jing G, Bai Y, Jiao M, Hu S, Liu Z, Guo H, Jiang L. Impact of NSAID type, initiation timing, duration and dose on clinical outcomes of immunotherapy in NSCLC: a multicenter two-cohort study. J Immunother Cancer. 2026 Apr 1;14(4):e014360. doi: 10.1136/jitc-2025-014360.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Malignant Neoplasm, run by First Affiliated Hospital Xi'an Jiaotong 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 6 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 7 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (PFS) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754983, which also lists 1 linked publication.
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 7 Feb 2025.