A randomized controlled trial of sirolimus-based immunosuppression versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001513

Enrollment

Unknown

Registered

2011-09-12

Start date

2009-03-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Hepatocellular carcinoma

Interventions

Control group:mTOR-inhibitor-free immunosuppression

Test group:sirolimus-based immunosuppression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with hepatocellular carcinoma (HCC) underwent liver transplantation; 2. Age over 18 years and under 65 years; 3. Tumors without major vascular invasion or exhapatic metastasis before LT; 4. Voluntary and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergic reactions or intolerance to experimental drugs; 2. Receiving other antineoplastic therapy (including medical, surgical, interventional, etc.) after liver transplantation; 3. Pregnant or lactating women; 4. Patients with renal insufficiency requiring dialysis, severe liver insufficiency (Child C), cardiac insufficiency (NY Heart Association class III–IV); 5. Pre-existing signs of bacteremia; 6. White cell count <1*10^9/L; 7. Other complications after operation leading to death or unfit to continue to participate in research 8. Any kind of psychosis.

Design outcomes

Primary

Measure	Time frame
incidence of adverse events(AE);rate of HCC recurrency;	—

Secondary

Measure	Time frame
recurrence-free survival;	—

Countries

China

Contacts

Public ContactYan Lunan

yanlunan128@163.com+86 18980601453

Outcome results

None listed

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