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A real-world prospective clinical study of carilizumab in the treatment of immune related endocrine diseases in patients with advanced malignant tumors

A real-world prospective clinical study of carilizumab in the treatment of immune related endocrine diseases in patients with advanced malignant tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035463
Enrollment
Unknown
Registered
2020-08-12
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Advanced malignant tumors

Interventions

Camrelizumab:none

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old patients, both male and female. 2. Patients must be clinically diagnosed as advanced malignant tumors (including advanced lung cancer, type III breast cancer, liver cancer, esophageal cancer, Hodgkin's lymphoma). 3. Patients who plan to use carrizumab. 4. Patients with an ECoG score of 0-1. 5. With the consent of the patient and the informed consent form has been signed, the patient is willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion criteria

Exclusion criteria: 1. Patients who have been previously treated with immunosuppressive agents (PD-1 / PD-L1 antibody, CTLA-4 antibody). 2. Patients with contraindications of carrizumab. 3. Patients with a history of thyroid dysfunction (including hyperthyroidism or hypothyroidism). 4. Patients with history of hypophysitis. 5. Patients with history of adrenocortical dysfunction. 6. Patients with a history of gonadal dysfunction. 7. Patients with severe or unstable angina pectoris, myocardial infarction, or ischemia requiring coronary artery bypass grafting or stenting, symptomatic congestive heart failure, arterial or venous thromboembolism events (e.g., pulmonary embolism, cerebrovascular accident, including transient cerebral ischemia), or ventricular arrhythmias of significant clinical significance within 6 months before enrollment or based on New York City Association (NYHA) class II to IV heart disease. 8. In patients with uncontrollable hypertension (continuous systolic blood pressure >= 160mmhg or diastolic blood pressure >= 100mmhg), if the blood pressure can be controlled within the above limits through antihypertensive treatment, subjects with hypertension history are allowed to be included in the study. 9. Patients with any history of active autoimmune disease or autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, vasculitis, nephritis). ten Patients with HIV infection or known acquired immunodeficiency syndrome (AIDS) and untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results Wu positive, HBV-DNA >= 500iu / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [HCV AB] positive, HCV-RNA higher than the detection method Limited and abnormal liver function) or co infection of hepatitis B and hepatitis C. 11. Patients with an ECoG score greater than 1. 12. Patients with a known history of psychotropic substance abuse or abuse. 13. Patients with other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered by the researchers to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Impact of immuno related endocrine events;

Secondary

MeasureTime frame
Incidence of immuno related endocrine events;Risk factors for immuno related endocrine events;Therapies of immuno related endocrine events;Quality of life;Biomarkers;Clinical care pathway;

Countries

China

Contacts

Public ContactYan Li

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

liyan19642012@sina.com+86 18620414146

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026