Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called donafenib to see how well it works and how safe it is for patients who have recently had surgery to remove liver cancer (known as hepatocellular carcinoma). The focus is on patients who are at high risk of their cancer coming back after surgery. The trial is taking place at multiple locations and is currently looking for participants.

To be eligible for this trial, you must have had surgery for liver cancer about four weeks ago and be considered at high risk for recurrence based on your tumor's characteristics. You should not have had any other cancer treatments before your surgery, except for a few specific therapies, and you need to be generally healthy with a good chance of living for at least three more months. If you join the trial, you will receive donafenib and be monitored closely to see how well it works for you and to check for any side effects. This trial is important as it could help improve treatment options for patients at risk of liver cancer returning.

Gender

ALL

Eligibility criteria

• 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