Solid TumorNCT07357636
Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors
An observational study of Solid Tumor and Immune-Related Adverse Events, run by Shantou University Medical College at 6 sites in China.
Trial summary
Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Immune-Related Adverse Events, Immunotherapy Toxicity
- How many people
- 940 participants
- Where
- 6 sitesChina
- Study dates
- 10 Jan 2019to 10 Sep 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with histologically confirmed solid malignancies who are initiating a new immune checkpoint inhibitor regimen, either as standard of care or within an approved clinical trial. Participants are enrolled prior to the first immune checkpoint inhibitor dose and followed longitudinally to assess the development of immune-related adverse events and associated immune and inflammatory biomarker changes.
Who may be able to join
- Age ≥18 years
- Histologically confirmed solid malignancy
- Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial
- Ability to provide informed consent
- Baseline study assessments and biospecimen collection completed prior to first ICI dose
- Life expectancy of at least 6 months as determined by treating oncologist
- Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable
Who cannot join
- Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation
- Chronic systemic immunosuppression exceeding 10 mg/day prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses)
- Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation
- Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days)
- Inability or unwillingness to provide required baseline biospecimens
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 430074
Yifei Ma, MD, 8618883852716, myf61872169@163.com
Yifei Ma, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Ao Zhang, MD, 8618588811852, zhangao@sysucc.org.cn
Ao Zhang, MD
- Recruiting
Hainan Hospital of Chinese PLA General Hospital
Sanya
Jiacai Lin, MD, 8615692537693, sovereignljc@126.com
Jiacai Lin, MD
- Recruiting
Affiliated Cancer Hospital of Shantou University Medical College
Shantou
Xinjia Wang, MD, 8613881841142, liuhaizhou@fjmu.edu.cn
Xinjia Wang, MD
- Recruiting
the First Affiliated Hospital of Shantou University Medical College
Shantou
Jun Lu, MD, 8613531263375, jlu1@stu.edu.cn
Jun Lu, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Pengfei Zhu, MD, 8613526664537, tesolik_trevolso@tom.com
Pengfei Zhu, MD
About this study
Official title: Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Receiving Immune Checkpoint Inhibitors, With Deep Phenotyping and Multi-Omics Biomarker Discovery
Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. While many irAEs are well recognized, neurological, neurocognitive, and psychiatric toxicities remain diagnostically challenging, potentially severe, and poorly understood, with limited predictive biomarkers.
This prospective longitudinal observational cohort study enrolls adult patients with solid tumors initiating a new course of ICI therapy. Participants undergo standardized baseline clinical assessments and biospecimen collection prior to ICI initiation, followed by longitudinal follow-up and event-driven sampling. Patients are dynamically assigned to organ-specific irAE cohorts based on the first clinically significant irAE that dictates management. Patients without grade ≥2 irAEs during follow-up serve as a comparator control cohort.
The primary objective is to characterize longitudinal immune and inflammatory biomarker trajectories associated with the development of irAEs and to identify predictive and prognostic biomarkers, with particular emphasis on neurological, neurocognitive, and psychiatric toxicities. Integrated clinical, imaging, and multi-omics data will be used to elucidate mechanisms of toxicity and inform future risk stratification and personalized management strategies.
Read the detailed description
Immune checkpoint inhibitors targeting CTLA-4, PD-1, and PD-L1 pathways have demonstrated substantial clinical benefit across multiple solid malignancies. However, their mechanism of action can also lead to immune-related adverse events (irAEs), which may involve dermatologic, gastrointestinal, hepatic, pulmonary, endocrine, musculoskeletal, cardiovascular, renal, hematologic, neurological, and psychiatric systems. Neurological and neurocognitive irAEs, in particular, are uncommon but potentially devastating and remain poorly characterized.
This study is a hybrid prospective longitudinal observational cohort designed to move beyond reactive identification of irAEs toward proactive prediction and mechanistic understanding. Adult patients with solid tumors initiating a new ICI regimen are enrolled prior to treatment initiation. Longitudinal clinical data, imaging, and biospecimens are collected at predefined intervals and at the time of suspected irAE onset when feasible.
Participants are assigned to event-defined cohorts based on the first grade ≥2 irAE that drives clinical management, including neuro-sensory, gastrointestinal/hepatic, rheumatologic/musculoskeletal, vascular/renal, hematologic, multi-organ, or control (no significant irAE) cohorts. Deep phenotyping and multi-omics analyses-including immune cell profiling, proteomics, metabolomics, and microbiome analyses-are performed to identify biomarkers associated with irAE risk, severity, and outcomes.
- Keywords
- Immune checkpoint inhibitors, Immunotherapy, Biomarkers, Neurotoxicity, Neuroimmune adverse events, immune related adverse events, PD-1 blocker
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Sensory irAE Cohort | Participants who develop a grade ≥2 neurological, neurocognitive, psychiatric, ocular inflammatory, or peripheral nervous system immune-related adverse event. | |
| Gastrointestinal and Hepatic irAE Cohort | Participants who develop grade ≥2 immune-mediated colitis, hepatitis, pancreatitis, or related gastrointestinal toxicities. | |
| Rheumatology and Musculoskeletal irAE Cohort | Participants who develop grade ≥2 inflammatory arthritis, myositis, polymyalgia rheumatica-like syndromes, or related musculoskeletal toxicities. | |
| Vascular and Renal irAE Cohort | Participants who develop grade ≥2 myocarditis, vasculitis, nephritis, or other vascular or renal immune-mediated toxicities. | |
| Hematologic irAE Cohort | Participants who develop grade ≥2 immune-mediated cytopenias or other hematologic toxicities. | |
| Multi-Organ irAE Cohort | Participants who develop two or more distinct grade ≥2 immune-related adverse events involving different organ systems. | |
| Control Cohort | Participants who do not develop any grade ≥2 immune-related adverse events during the defined follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Resolution of Immune-Related Adverse Events (Days)
Among participants who develop grade ≥2 immune-related adverse events (irAEs), the time from irAE diagnosis and initiation of organ-specific treatment (per institutional guidelines) to achievement of organ-specific clinical resolution will be recorded. Criteria for clinical resolution differ by organ system and are defined according to established consensus guidelines, as specified in the corresponding secondary outcome measures.
Measured: From irAE diagnosis through up to 24 months of follow-up
Secondary outcomes (15)
Neuro-Sensory irAE Subgroup: Proportion of Participants with Modified Rankin Scale (mRS) Score ≤2
Among participants with immune-mediated neurological events (e.g., encephalitis, myelitis, plexopathy), functional status will be assessed using the Modified Rankin Scale. An mRS score ≤2 (slight disability, able to live independently) is a widely accepted threshold for favorable neurological outcome in neuroimmunology clinical trials.
Measured: 12 weeks after irAE diagnosis
Neuro-Sensory irAE Subgroup:Proportion of Participants with Objective Improvement on Nerve Conduction Studies
Among participants with immune-mediated peripheral neuropathy, electrophysiologic improvement will be assessed using nerve conduction studies and electromyography. Objective improvement is defined as ≥20% improvement in motor or sensory nerve action potential amplitude or conduction velocity compared with the acute phase, according to EFNS/PNS criteria.
Measured: 12 weeks after irAE diagnosis
Psychiatric and Cognitive irAE Subgroup:Proportion of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <10
Among participants with immune-mediated major depressive episodes, depressive symptoms will be assessed using the PHQ-9. A score <10 represents remission or mild symptoms and is an internationally accepted threshold distinguishing clinically significant depression from response/remission.
Measured: 8 weeks after initiation of targeted treatment
Psychiatric and Cognitive irAE Subgroup:Proportion of Participants with ≥0.5 Standard Deviation Improvement on ≥2 Standardized Neuropsychological Tests
Among participants with immune-mediated cognitive impairment, standardized neuropsychological test batteries (including the Hopkins Verbal Learning Test-Revised and Trail Making Test Part B) will be administered. Clinically meaningful cognitive improvement is defined as ≥0.5 standard deviation improvement from the acute phase in at least two distinct cognitive domains.
Measured: 12 weeks after irAE diagnosis
Gastrointestinal and Hepatic irAE Subgroup: Proportion of Participants with ≤3 Bowel Movements per Day and No Hematochezia
Among participants with immune-mediated colitis, clinical remission will be assessed. ≤3 bowel movements per day without hematochezia is a widely accepted clinical remission criterion in colitis clinical trials.
Measured: 2 weeks after initiation of immunosuppressive therapy
Gastrointestinal and Hepatic irAE Subgroup: Proportion of Participants with Alanine Aminotransferase (ALT) ≤1.5 × Upper Limit of Normal
Among participants with immune-mediated hepatitis, biochemical remission will be assessed. ALT ≤1.5 × ULN is a commonly accepted biochemical remission criterion in drug-induced liver injury trials.
Measured: 4 weeks after initiation of immunosuppressive therapy
Rheumatologic and Musculoskeletal irAE Subgroup: Proportion of Participants with Clinical Disease Activity Index (CDAI) ≤10
Among participants with immune-mediated inflammatory arthritis, disease activity will be assessed using the CDAI. A CDAI score ≤10 defines low disease activity and is an established rheumatologic threshold.
Measured: 12 weeks after initiation of immunosuppressive therapy
Rheumatologic and Musculoskeletal irAE Subgroup: Proportion of Participants with ≥20% Improvement in Manual Muscle Testing (MMT-8) Score
Among participants with immune-mediated myositis, muscle strength will be assessed using the MMT-8 score. A ≥20% improvement from the acute phase is an established clinically meaningful threshold in myositis trials.
Measured: 12 weeks after irAE diagnosis
Renal irAE Subgroup: Proportion of Participants with Serum Creatinine Recovery to Within 1.3 × Baseline
Among participants with immune-mediated nephritis, renal recovery will be assessed. Serum creatinine recovery to within 1.3 × baseline represents a stringent and clinically meaningful recovery criterion per KDIGO acute kidney injury guidelines.
Measured: 12 weeks after irAE diagnosis
Hematologic irAE Subgroup: Proportion of Participants with Sustained Hematologic Response (CTCAE v5.0 Grade ≤1 for ≥4 Weeks)
Among participants with immune-mediated cytopenias, hematologic remission is defined as maintenance of CTCAE v5.0 grade ≤1 blood counts (e.g., platelets ≥75 ×10⁹/L, absolute neutrophil count ≥1.5 ×10⁹/L) for at least 4 weeks without ongoing transfusion or growth factor support.
Measured: Within 12 weeks after initiation of first-line immunosuppressive therapy
Hematologic irAE Subgroup: Proportion of Participants with Normalized Lactate Dehydrogenase and Stable Hemoglobin
Among participants with immune-mediated hemolytic anemia, hemolysis control is defined as normalization of lactate dehydrogenase with stable hemoglobin levels for ≥7 days without transfusion support.
Measured: 2 weeks after initiation of treatment
Multi-Organ irAE Subgroup: Proportion of Participants without Any New or Worsening ≥Grade 3 Immune-Related Adverse Events Across Organ Systems
Among participants with multi-organ irAEs, overall toxicity control is defined as absence of any new or worsening grade ≥3 irAE in any organ system following initiation of treatment.
Measured: Within 4 weeks after initiation of combined immunosuppressive therapy
Multi-Organ irAE Subgroup: Proportion of Participants Requiring Intensive Care Unit Admission for Multi-Organ irAE
The proportion of participants requiring intensive care unit admission due to the severity of multi-organ immune-related adverse events will be recorded as an objective marker of disease severity.
Measured: irAE diagnosis through resolution or up to 24 weeks
Control Cohort (No Grade ≥2 irAE): Duration of Immunotherapy without Grade ≥2 Immune-Related Adverse Events (Months)
Among participants who do not develop grade ≥2 irAEs, treatment tolerability will be assessed as the time from ICI initiation to first occurrence of grade ≥2 irAE, disease progression, death, or treatment discontinuation.
Measured: From ICI initiation through 90 days after last dose
Control Cohort (No Grade ≥2 irAE): Proportion of Participants Completing Planned Immune Checkpoint Inhibitor Course per Protocol
Among participants without grade ≥2 irAEs, the proportion completing the planned ICI treatment course as scheduled will be recorded as a complementary measure of treatment tolerability.
Measured: From ICI initiation through 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Jan 2019
- Primary completion10 Sep 2029 (estimated)
- Study completion10 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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
- 940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University, The First Affiliated Hospital of Zhengzhou University, Sun Yat-sen University, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Weidong Wang, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357636
- Sponsor's protocol ID
- 2023100
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Baseline Characteristics \& Demographics: Age, sex, race/ethnicity, baseline body weight and height, diagnosis, treatment history, relevant comorbidities, smoking/alcohol status. 2. Exposure/Treatment Data: Specific checkpoint inhibitor(s) received, dosing regimen, treatment start and end dates, medications. 3. Laboratory \& Diagnostic Data: Serial laboratory test results, key imaging findings relevant to irAEs, pathology reports. 4. Outcomes: CTCAE grades, date to primary outcomes, management strategies. 5. Oncologic Outcomes: Tumor response assessments. 6. Supporting Documents for Data Interpretation.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Receiving Immune Checkpoint Inhibitors, With Deep Phenotyping and Multi-Omics Biomarker Discovery
- ClinicalTrials.gov ID
- NCT07357636
- Acronym / sponsor ID
- 2023100
- Keywords
- Immune checkpoint inhibitors, Immunotherapy, Biomarkers, Neurotoxicity, Neuroimmune adverse events, immune related adverse events, PD-1 blocker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 940 participants (estimated)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Collaborators
- Fujian Medical University, The First Affiliated Hospital of Zhengzhou University, Sun Yat-sen University, Chinese PLA General Hospital
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Sep 2029 (estimated)
- Study completion
- 10 Sep 2029 (estimated)
- First posted
- 22 Jan 2026 (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.
Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. While many irAEs are well recognized, neurological, neurocognitive, and psychiatric toxicities remain diagnostically challenging, potentially severe, and poorly understood, with limited predictive biomarkers.
This prospective longitudinal observational cohort study enrolls adult patients with solid tumors initiating a new course of ICI therapy. Participants undergo standardized baseline clinical assessments and biospecimen collection prior to ICI initiation, followed by longitudinal follow-up and event-driven sampling. Patients are dynamically assigned to organ-specific irAE cohorts based on the first clinically significant irAE that dictates management. Patients without grade ≥2 irAEs during follow-up serve as a comparator control cohort.
The primary objective is to characterize longitudinal immune and inflammatory biomarker trajectories associated with the development of irAEs and to identify predictive and prognostic biomarkers, with particular emphasis on neurological, neurocognitive, and psychiatric toxicities. Integrated clinical, imaging, and multi-omics data will be used to elucidate mechanisms of toxicity and inform future risk stratification and personalized management strategies.
Detailed description
Immune checkpoint inhibitors targeting CTLA-4, PD-1, and PD-L1 pathways have demonstrated substantial clinical benefit across multiple solid malignancies. However, their mechanism of action can also lead to immune-related adverse events (irAEs), which may involve dermatologic, gastrointestinal, hepatic, pulmonary, endocrine, musculoskeletal, cardiovascular, renal, hematologic, neurological, and psychiatric systems. Neurological and neurocognitive irAEs, in particular, are uncommon but potentially devastating and remain poorly characterized.
This study is a hybrid prospective longitudinal observational cohort designed to move beyond reactive identification of irAEs toward proactive prediction and mechanistic understanding. Adult patients with solid tumors initiating a new ICI regimen are enrolled prior to treatment initiation. Longitudinal clinical data, imaging, and biospecimens are collected at predefined intervals and at the time of suspected irAE onset when feasible.
Participants are assigned to event-defined cohorts based on the first grade ≥2 irAE that drives clinical management, including neuro-sensory, gastrointestinal/hepatic, rheumatologic/musculoskeletal, vascular/renal, hematologic, multi-organ, or control (no significant irAE) cohorts. Deep phenotyping and multi-omics analyses-including immune cell profiling, proteomics, metabolomics, and microbiome analyses-are performed to identify biomarkers associated with irAE risk, severity, and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Neuro-Sensory irAE Cohort | – | –Participants who develop a grade ≥2 neurological, neurocognitive, psychiatric, ocular inflammatory, or peripheral nervous system immune-related adverse event. |
| Gastrointestinal and Hepatic irAE Cohort | – | –Participants who develop grade ≥2 immune-mediated colitis, hepatitis, pancreatitis, or related gastrointestinal toxicities. |
| Rheumatology and Musculoskeletal irAE Cohort | – | –Participants who develop grade ≥2 inflammatory arthritis, myositis, polymyalgia rheumatica-like syndromes, or related musculoskeletal toxicities. |
| Vascular and Renal irAE Cohort | – | –Participants who develop grade ≥2 myocarditis, vasculitis, nephritis, or other vascular or renal immune-mediated toxicities. |
| Hematologic irAE Cohort | – | –Participants who develop grade ≥2 immune-mediated cytopenias or other hematologic toxicities. |
| Multi-Organ irAE Cohort | – | –Participants who develop two or more distinct grade ≥2 immune-related adverse events involving different organ systems. |
| Control Cohort | – | –Participants who do not develop any grade ≥2 immune-related adverse events during the defined follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with histologically confirmed solid malignancies who are initiating a new immune checkpoint inhibitor regimen, either as standard of care or within an approved clinical trial. Participants are enrolled prior to the first immune checkpoint inhibitor dose and followed longitudinally to assess the development of immune-related adverse events and associated immune and inflammatory biomarker changes.
Key inclusion criteria (7 listed)
- Age ≥18 years
- Histologically confirmed solid malignancy
- Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial
- Ability to provide informed consent
- Baseline study assessments and biospecimen collection completed prior to first ICI dose
Key exclusion criteria (5 listed)
- Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation
- Chronic systemic immunosuppression exceeding 10 mg/day prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses)
- Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation
- Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days)
- Inability or unwillingness to provide required baseline biospecimens
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
Time to Clinical Resolution of Immune-Related Adverse Events (Days)
Time frame: From irAE diagnosis through up to 24 months of follow-up
Among participants who develop grade ≥2 immune-related adverse events (irAEs), the time from irAE diagnosis and initiation of organ-specific treatment (per institutional guidelines) to achievement of organ-specific clinical resolution will be recorded. Criteria for clinical resolution differ by organ system and are defined according to established consensus guidelines, as specified in the corresponding secondary outcome measures.
15 secondary outcomes
Neuro-Sensory irAE Subgroup: Proportion of Participants with Modified Rankin Scale (mRS) Score ≤2
Time frame: 12 weeks after irAE diagnosis
Neuro-Sensory irAE Subgroup:Proportion of Participants with Objective Improvement on Nerve Conduction Studies
Time frame: 12 weeks after irAE diagnosis
Psychiatric and Cognitive irAE Subgroup:Proportion of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <10
Time frame: 8 weeks after initiation of targeted treatment
Psychiatric and Cognitive irAE Subgroup:Proportion of Participants with ≥0.5 Standard Deviation Improvement on ≥2 Standardized Neuropsychological Tests
Time frame: 12 weeks after irAE diagnosis
Gastrointestinal and Hepatic irAE Subgroup: Proportion of Participants with ≤3 Bowel Movements per Day and No Hematochezia
Time frame: 2 weeks after initiation of immunosuppressive therapy
Gastrointestinal and Hepatic irAE Subgroup: Proportion of Participants with Alanine Aminotransferase (ALT) ≤1.5 × Upper Limit of Normal
Time frame: 4 weeks after initiation of immunosuppressive therapy
Rheumatologic and Musculoskeletal irAE Subgroup: Proportion of Participants with Clinical Disease Activity Index (CDAI) ≤10
Time frame: 12 weeks after initiation of immunosuppressive therapy
Rheumatologic and Musculoskeletal irAE Subgroup: Proportion of Participants with ≥20% Improvement in Manual Muscle Testing (MMT-8) Score
Time frame: 12 weeks after irAE diagnosis
Renal irAE Subgroup: Proportion of Participants with Serum Creatinine Recovery to Within 1.3 × Baseline
Time frame: 12 weeks after irAE diagnosis
Hematologic irAE Subgroup: Proportion of Participants with Sustained Hematologic Response (CTCAE v5.0 Grade ≤1 for ≥4 Weeks)
Time frame: Within 12 weeks after initiation of first-line immunosuppressive therapy
Hematologic irAE Subgroup: Proportion of Participants with Normalized Lactate Dehydrogenase and Stable Hemoglobin
Time frame: 2 weeks after initiation of treatment
Multi-Organ irAE Subgroup: Proportion of Participants without Any New or Worsening ≥Grade 3 Immune-Related Adverse Events Across Organ Systems
Time frame: Within 4 weeks after initiation of combined immunosuppressive therapy
Multi-Organ irAE Subgroup: Proportion of Participants Requiring Intensive Care Unit Admission for Multi-Organ irAE
Time frame: irAE diagnosis through resolution or up to 24 weeks
Control Cohort (No Grade ≥2 irAE): Duration of Immunotherapy without Grade ≥2 Immune-Related Adverse Events (Months)
Time frame: From ICI initiation through 90 days after last dose
Control Cohort (No Grade ≥2 irAE): Proportion of Participants Completing Planned Immune Checkpoint Inhibitor Course per Protocol
Time frame: From ICI initiation through 90 days after last dose
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 28 Jan 2026.
- Individual participant dataSharing planned: Yes. 1. Baseline Characteristics \& Demographics: Age, sex, race/ethnicity, baseline body weight and height, diagnosis, treatment history, relevant comorbidities, smoking/alcohol status. 2. Exposure/Treatment Data: Specific checkpoint inhibitor(s) received, dosing regimen, treatment start and end dates, medications. 3. Laboratory \& Diagnostic Data: Serial laboratory test results, key imaging findings relevant to irAEs, pathology reports. 4. Outcomes: CTCAE grades, date to primary outcomes, management strategies. 5. Oncologic Outcomes: Tumor response assessments. 6. Supporting Documents for Data Interpretation.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Immune-Related Adverse Events, run by Shantou University Medical College at 6 sites 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 7 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Contact Yifei Ma, MD (8618883852716, myf61872169@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Resolution of Immune-Related Adverse Events (Days) (time frame: From irAE diagnosis through up to 24 months of follow-up). 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 28 Jan 2026.