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A randomized controlled clinical study of the overall management of adverse reactions to immune checkpoint inhibitors

A randomized controlled clinical study of the overall management of adverse reactions to immune checkpoint inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092018
Enrollment
Unknown
Registered
2024-11-07
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Tumor

Interventions

Control groups:Conventional management
Intervention group:Overall management:

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Agree to join the group and sign the informed consent; 2. Use immune checkpoint inhibitors; 3. Age 18 and above, regardless of gender; 4. Pathological diagnosis of malignant tumor; 5.ECOG PS score 0-1; 6. Liver function: For patients without liver primary or metastatic tumors, ALT, AST and ALP should be =90ml/min are required before ICIs treatment; Patients with primary or metastatic renal tumors were required to have creatinine =60ml/min. 8. The expected survival is greater than 3 months.

Exclusion criteria

Exclusion criteria: 1.Patients with serious underlying diseases, including symptomatic congestive heart failure, myocardial infarction, cerebral infarction, and interstitial lung disease before screening; 2.Patients with acute infection; 3.Patients who are difficult to cooperate with the implementation of the program, such as patients with consciousness disorders or cognitive disorders, patients with mental disorders, patients who can not receive follow-up as planned; 4.Pregnant or lactating women; 5.Other conditions that researchers believe are not suitable for participation, such as poor compliance.

Design outcomes

Primary

MeasureTime frame
24h treatment rate of adverse reactions;

Secondary

MeasureTime frame
Permanent discontinuation rate due to adverse reactions;Time of discovery of new adverse reactions;Mortality due to adverse reactions;Patient Quality of life (EQ-5D);Adverse reaction treatment time;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactZheng Xiaowei

Zhejiang Provincial People's Hospital

zhengxw@zjcc.org.cn+86 571 85893643

Outcome results

None listed

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