Objective   To investigate initially the availability and safety of combined application of sirolimus, thymosin α-1(Tα-1) and Huaier granule in preventing tumor recurrence of terminal primary liver cancer(TPLC) after liver transplantation(LT).

  Methods   Combination group included 12 patients with TPLC who underwent LT in the 309^th hospital of Chinese People's Liberation Army from 2010 to 2012(all conform to Hangzhou standard). And historical control group included 15 patients with TPLC underwent LT at the same hospital from 2002 to 2006, whose follow up data was true and precise. During 1 month after LT, the type or dose of immunosuppressors was adjusted according to the individual differences of patients. Tacrolimus(FK506) and mycophenolate mofetil(MMF) were given to patients at first, and FK506 was gradually withdrawn and insteaded by sirolimus at 1 month after LT. Methylprednisolone of 500 mg was given during operation. Then small dose of methylprednisolone was given after operation and withdrawn at 1 week after LT. At the same time Tα-1 and Huaier Granule were added. The Tα-1 was injected for 10 days(1.6 mg per time, once a day), and after that injected twice a week. Huaier granule was given 20 g per time and three times a day. All the patients had been followed up. All the data including serum alpha-fetoprotein(AFP) changes, occurrence of allograft rejection, recurrence and treatment, survival time were collected accurately.

  Results   In the combination group, the 12 cases were followed up for 8-35 months with the median follow up time of 18 months without loss or drop-out. All patients were survived. In the historical control group, the medium follow up time was 14 months till all the patients died. In the combination group, 2 cases developed isolated pulmonary metastasis after LT and 2 cases deveoped multiple pulmonary metastasis. All of the four cases were cured with the treatment of γ-knife. In history control group, 7 cases developed recurrence in 6 months after LT and all of the 15 cases developed recurrence in 1 year after LT. All of the 15 cases developed pulmonary metastasis(6 cases were isolated and 9 cases were multiple). All cases died of multi-section of tumor metastasis.

  Conclusions   Combined application of sirolimus, Tα-1 and Huaier granule have significantly effect on preventing tumor recurrence of TPLC after LT, delaying tumor recurrence and prolonging survival time of patients.