Combining donafenib with chemoembolization for liver cancer treatment before transplantation

Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation: a Single-arm Exploratory Study

This study is testing if combining a medication called donafenib with a treatment called chemoembolization can help people with liver cancer who are not eligible for a transplant get better before they undergo the procedure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Drugs / interventions: lenvatinib, regofinib, apatinib, ambrotinib, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05576909 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of donafenib in combination with transarterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC) who do not meet the UCSF criteria for liver transplantation. Approximately 20 patients will be enrolled and treated with donafenib and TACE during the downstaging period, followed by donafenib alone in the adjuvant period after transplantation. Safety and efficacy assessments will occur at regular intervals before and after the liver transplant until certain endpoints are reached.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with hepatocellular carcinoma who do not meet UCSF criteria but have manageable disease characteristics.

Not a fit: Patients with mixed-type hepatocellular carcinoma or those with significant vascular invasion or metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with hepatocellular carcinoma awaiting liver transplantation.

How similar studies have performed: Other studies have shown promise in using similar approaches for treating hepatocellular carcinoma, but this specific combination is relatively novel.

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.);

Where this trial is running

Beijing

• Beijing Tsinghua Changgung Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lu Qian

Conditions Hepatocellular Carcinoma