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Construction and Application of a Prediction Model for Immune Checkpoint Inhibitor–Related Adverse Events

Construction and Application of a Prediction Model for Immune Checkpoint Inhibitor–Related Adverse Events

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115737
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Gastrointestinal Tumors

Interventions

Observation group:NONE

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18 years or above, with a clear pathological diagnosis of primary hepatocellular carcinoma, gastric cancer, esophageal cancer, colorectal cancer, etc. (2) Have received at least one cycle of ICIs monotherapy or dual therapy or combination chemotherapy. (3) Are aware of the diagnosis and condition. (4) Have clear consciousness and can understand the content of this study, and can communicate and answer questions effectively through written, electronic devices or interviews. (5) Have given informed consent and are voluntarily participating in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Suffering from other serious diseases simultaneously: For instance, having uncontrolled severe infections, severe cardiovascular or cerebrovascular diseases (such as unstable angina pectoris, myocardial infarction within the past 6 months), uncontrolled epilepsy or central nervous system disorders, etc. The researchers will determine that the participant is not suitable for participation. (2) Having mental or cognitive impairments: For example, having a history of mental illness, cognitive dysfunction or any other condition that prevents understanding the study requirements or accurately reporting one's own feelings. (3) Having other conditions that affect the assessment, such as active autoimmune diseases, interstitial lung disease, conditions requiring immunosuppressive therapy, pregnancy, etc.

Design outcomes

Primary

MeasureTime frame
Symptom cognition and incidence of adverse reactions;self-management;quality of life;health literacy;

Secondary

MeasureTime frame
Psychological symptoms;oral frailty;

Countries

China

Contacts

Public ContactTao Li

Henan Cancer Hospital

yijingna@zzu.edu.cn+86 180 0386 1619

Outcome results

None listed

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