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A prospective, multicenter clinical study on myocarditis induced by immune checkpoint inhibitor therapy in tumor patients

A prospective, multicenter clinical study on myocarditis induced by immune checkpoint inhibitor therapy in tumor patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121839
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-03
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor

Interventions

The group for observing solid tumors:None

Sponsors

Eastern Theater General Hospital of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with a confirmed diagnosis of solid tumor via cytological or histological pathological examination; 2. Patients scheduled to receive at least one cycle of immune checkpoint inhibitor (ICIs) therapy (including monotherapy and combination therapy regimens; ICIs mainly include PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, PD-1+VEGF bispecific antibodies, PD-1+CTLA-4 bispecific antibodies (bispecific antibodies or combined dual antibodies), etc., excluding cell infusion therapies such as DC, CIK, and CAR-T); 3. Patients with normal cognitive function who can understand and complete the patient adverse reaction questionnaires and relevant scales required by the study; 4. Patients who have voluntarily signed this informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular underlying diseases (Class II or above congestive heart failure, unstable angina pectoris, myocardial infarction, uncontrolled arrhythmias); 2. Previous radiotherapy to the left chest or heart, or heart surgery (including stent, valve, etc. surgeries); 3. Severe mental disorders, as judged by the researchers, that prevent the participant from completing the study; 4. Poor compliance or the researchers' judgment that the participant is unable to complete the study in any circumstances.

Design outcomes

Primary

MeasureTime frame
The incidence rate of immune-mediated myocarditis;Prognosis;

Countries

China

Contacts

Public ContactXiaoyuan Chu,Feng Wang

Eastern Theater General Hospital of the Chinese People's Liberation Army

chuxiaoyuan00@gmail.com+86 137 7064 8777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026