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Pilot study on the second-line treatment of sirolimus for steroid-refractory immune checkpoint inhibitor-related liver injury

Pilot study on the second-line treatment of sirolimus for steroid-refractory immune checkpoint inhibitor-related liver injury

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105086
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Immune checkpoint inhibitors-induced liver injury

Interventions

Sponsors

Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) malignant tumor patients with grade 3 or above liver injury after receiving immune checkpoint inhibitors (2) There was no significant improvement in liver function after 3 days of glucocorticoid treatment; (3) ECOG PS score <= 2; (4) age between 18 and 75 years old, male or female; (5) Willing to sign The informed consent form.

Exclusion criteria

Exclusion criteria: (1) severe infection and active tuberculosis; (2) uncontrolled diabetes and hypertension; (3) multiple organ failure; (4) end-stage malignant tumors; (5) pregnant and lactating women;

Design outcomes

Primary

MeasureTime frame
Secondary Infection;hyperglycaemia;

Secondary

MeasureTime frame
liver function test;coagulation function;

Countries

China

Contacts

Public ContactLi Chen

Ruijin Hospital, Shanghai Jiaotong University, School of Medicine

drchenli@163.com+86 181 2126 6353

Outcome results

None listed

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