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

• Status: Not yet recruiting
• Trial end date: 2025-10-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of the combination of donafenib and TACE in the perioperative period of liver transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital
• Collaborator: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.);