Hepatocellular carcinoma
Conditions
Interventions
Control group:The basiliximab induction regimen was defined as follows: two intravenous infusions of 20 mg each, administered over 30 minutes on the day of transplantation (D0) and on postoperative da
Study group:ATLG was administered by intravenous infusion, continuously or intermittently, from the day of transplantation through postoperative day 7 (D0–D7), with a maximum single-day dose of 200 mg
infusion rates could be further decreased in response to infusion-related adverse events.
Premedication with corticosteroids and antihistamines was given to prevent infusion reactions. Methylpredni
40 mg/day IV on D4–D6
20 mg/day IV on D6–D7
with discontinuation on D8.
Tacrolimus monotherapy was initiated on postoperative day 3 at an initial dose of 2 mg every 12 hours, targeting whole-blood trough concentrations of 8–10 ng/mL during t
Sponsors
Huashan hospital affiliated to Fudan university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) >=18 years old, regardless of gender; (2) Hepatocellular carcinoma (HCC) confirmed by histology and/or cytology; (3) Liver cancer patients undergoing liver transplantation for the first time; (4) Received =1 dose of ICIs treatment (including PD-1 and PD-L1 inhibitors) before liver transplantation, with ICIs discontinued >30 days prior to surgery; (5) Patients who have previously received local treatment for liver cancer or other systemic treatment methods (including chemotherapy and targeted drug therapy) are eligible for enrollment; (6) Patients have given informed consent to the treatment and trial protocol.
Exclusion criteria
Exclusion criteria: (1) Recipients undergoing combined organ transplantation; (2) Incomplete clinical and pathological data; (3) Patients with severe underlying diseases, including heart, brain, and other organ failures; (4) Patients with autoimmune diseases; (5) Patients with cognitive impairment; (6) Those who develop primary non-function (PNF) of the transplanted liver postoperatively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of early postoperative rejection (within 3 months) (whether rejection occurs and the severity of the rejection); | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of early postoperative infections (within 3 months);Recurrence of liver cancer within 1 year postoperatively;Occurrence of graft loss within 1 year postoperatively;Recipient survival within 1 year postoperatively; | — |
Countries
China
Contacts
Public ContactWang Zhengxin
Huashan hospital affiliated to Fudan university
Outcome results
None listed