Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation

Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Oct 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called donafenib when used together with a procedure called hepatic artery chemoembolization (TACE) for patients undergoing liver transplantation due to liver cancer, specifically hepatocellular carcinoma (HCC). The goal is to see if this combination treatment can help improve outcomes for patients during the period surrounding their liver transplant surgery.

To participate in this study, patients must be diagnosed with HCC and have at least one measurable liver tumor. They should not have had more than one previous TACE treatment within the past six months, and their liver function should be stable. Eligible participants will be closely monitored throughout the trial. It's important to note that some patients may not qualify if they have certain complications or have received specific prior treatments. Overall, this trial aims to offer new hope for patients with liver cancer who are preparing for transplantation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of HCC either by biopsy or according to AASLD criteria;
• • 2. At least one measurable lesion according to mRECIST;
• • 3. The previous palliative TACE treatment did not exceed one time, with an interval of ≥ 6 months; For patients who had received one prior TACE treatment, the treated lession progressed or lipiodol deposition was less than 50%;
• • 4. Child-Pugh class ≤ 7;
• • 5. ECOG Performance Status 0-1;
• 6. Intrahepatic tumors meet any of the following conditions:
• • Beyond the UCSF standard, no more than 5 intrahepatic tumors with the longest diameters ≤ 10cm, no tumor thrombus in the main portal vein
• • Meet the UCSF standard, but AFP \> 1000 ng / ml
• Exclusion Criteria:
• • 1. The pathological diagnosis was hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed type or fibrous lamellar hepatocellular carcinoma;
• • 2. There were inferior vena cava cancer thrombus, hepatic vein cancer thrombus, regional lymph node invasion or extrahepatic metastasis;
• • 3. HCC recurred within 2 years after radical resection or ablation;
• • 4. Patients who have received prior liver transplantation, ≥ 2 times of palliative TACE or other palliative local treatment (including HAIC, radiotherapy, etc.), but who have received prior radical hepatectomy, radical ablation and preventive TACE for the purpose of anti-recurrence can be enrolled;
• • 5. Prior or ongoing systemic therapy (including systemic therapeutic drugs under research, excluding antiviral therapy), including but not limited to TKI such as sorafenib, lenvatinib, regofinib, apatinib, and ambrotinib, PD-1 / PD-L1 monoclonal antibody or immunotherapy against PD-1 / PD-L1, etc;
• • 6. There are contraindications to TACE determined by the investigators (e.g., portal vein trunk obstruction without formation of collateral vessels, etc.);