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Establishment and evaluation of pharmaceutical care mode based on clinical research of immune related adverse events

Establishment and evaluation of pharmaceutical care mode based on clinical research of immune related adverse events

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060811
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

immune related adverse events

Interventions

case series:No

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.It met the diagnostic criteria for the indications of carrelizumab and was clearly diagnosed by pathological examination; 2.Hodgkin's lymphoma, advanced hepatocellular carcinoma and liver cancer treated with or to be treated with camrelizumab alone or in combination; Patients with metastatic NSCLC, esophageal squamous cell carcinoma and nasopharyngeal carcinoma; 3.Aged 18 - 70 years; 4.KPS score >= 60, estimated survival >= 3 months; 5.Volunteers must give informed consent to the study before the test and sign the informed consent form before screening.

Exclusion criteria

Exclusion criteria: 1.Poor compliance during clinical research and failure to cooperate with follow-up and TDM blood sample collection; 2.No definite pathological diagnosis; 3.Receiving camrelizumab alone or combined chemotherapy for >= 12 months; 4.Subjects who did not implement the provisions of this experimental protocol and received carilizumab on schedule; 5.Subjects whose observation items are incomplete and unable to evaluate the occurrence of Irae; 6.Patients with severe immune related adverse drug reactions and drug withdrawal in the past, such as gastrointestinal discomfort caused by drugs; 7.During the follow-up period, the use of calizumab was stopped.

Design outcomes

Primary

MeasureTime frame
Serum camrelizumab concentration;

Countries

China

Contacts

Public ContactWang Zhuo

Shanghai Changhai Hospital

wangzhuo088@163.com+86 13818390863

Outcome results

None listed

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