Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Summary

This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Eligibility

Inclusion Criteria:

* Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
* High Risk of recurrence as assessed by tumor characteristics
* Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
* Child-Pugh Class A statu
* ECOG Performance Status of 0 or 1
* CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
* Expected survival time of no less than 3 months

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Evidence of residual or a history of spontaneous tumor rupture
* Recurrent HCC
* Prior received Liver transplantation
* Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
* AFP does not return to normal 4 weeks after operation

Conditions5

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