Malignant TumorNCT05862259
A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies
An observational study of Malignant Tumor and Immunotherapy, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumor, Immunotherapy, Artificial Intelligence
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: receiving immunotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037
jianguo sun, Phd, 023-68774490, sunjg09@aliyun.com
About this study
Official 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
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
- Conditions
- Malignant Tumor, Immunotherapy, Artificial Intelligence
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time between randomization and the first occurrence of disease progression or death from any cause
Measured: six months
Secondary outcomes (3)
Overall survival
Time from randomization to death from any cause
Measured: two years
Objective response rate
Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements
Measured: one years
Immune-Related Adverse Events
In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,
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 posted17 May 2023
- Study start10 Aug 2023
- Primary completion10 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862259
- Sponsor's protocol ID
- XQonc-021
- Status last verified
- Jul 2025
- First submitted
- 8 May 2023
- Last updated
- 14 Jul 2025
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05862259
- Acronym / sponsor ID
- XQonc-021
- Conditions
- Malignant Tumor, Immunotherapy, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 May 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- receiving immunotherapy
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Time frame: six months
The time between randomization and the first occurrence of disease progression or death from any cause
3 secondary outcomes
Overall survival
Time frame: two years
Objective response rate
Time frame: one years
Immune-Related Adverse Events
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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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.
the second affiliated hospital of Army medical university
Chongqing, China
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 Tumor and Immunotherapy, run by Xinqiao Hospital of Chongqing 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 4 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: looking for participants now, as of the sponsor's last update on 14 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: six 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 14 Jul 2025.