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The Efficacy and Safety of Sirolimus Early Conversion Protocol in Liver Transplant Patients with Hepatocellular Carcinoma: a Single-Arm, Multi-Center, Prospective Study

The Efficacy and Safety of Sirolimus Early Conversion Protocol in Liver Transplant Patients with Hepatocellular Carcinoma: a Single-Arm, Multi-Center, Prospective Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042869
Enrollment
Unknown
Registered
2021-01-30
Start date
2021-02-15
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Hepatocellular carcinoma

Interventions

Sponsors

Shulan (Hangzhou) hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who signed informed consent voluntarily; 2. Subjects aged from 18 to 70 years; 3. Recipients of liver transplantation with liver cancer who have received organ donation and living donor after the citizen's death, and who have exceeded Milan standard, have no major vascular invasion except portal vein branch, and have no distant metastasis; 4. The subjects confirmed by histopathology as hepatocellular carcinoma.

Exclusion criteria

Exclusion criteria: 1. Patients with multiple organ transplantation; 2. Patients with high sensitivity to sirolimus or its derivatives have been identified; 3. Patients with Refractory Hyperlipidemia (triglyceride >= 400 mg / dl (>= 4.6 mmol / L) and total cholesterol >= 300 mg / dl (>= 7.8 mmol / L) still exist under the best treatment scheme; 4. Patients with signs of systemic infection or important local active infection; 5. HIV positive patients; 6. Patients with platelet < 35 x 10^9 / L and leukocyte < 1.5 x 10^9 / L; 7. Patients with urinary albumin + +; A woman who is preparing for pregnancy or lactation; 9. Patients with a history of non hepatocellular carcinoma (except basal cell carcinoma and squamous cell carcinoma) in the previous 5 years were enrolled; 10. Patients who are difficult to cooperate with the implementation of the research program and follow-up plan in terms of psychological, family, social or geographical conditions (such as individuals who cannot freely sign informed consent).

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival;

Secondary

MeasureTime frame
Tumor-related death;incidence of allograft rejection;incidence of graft loss;alterations in renal function;

Countries

China

Contacts

Public ContactShusen Zheng

Shulan (Hangzhou) hospital

zyzsss@zju.edu.cn+86 571-86783590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026