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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576909
• Other study ID #: DPM-HCC-N03
• Status: Recruiting
• Phase: Phase 2
• Start date: March 30, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: August 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Lu Qian
• Phone: 15810088530
• Email: luqianbtch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study plans to enroll about 20 patients with hepatocellular carcinoma (HCC) who do not meet the UCSF standard, they will receive donafenib combined with TACE in downstaging period and donafenib only in adjuvant period.

Before the liver transplantation, the safety and efficacy will be evaluated every 3 and 6 weeks, respectively, until liver transplantation or the disease progression that couldn't be treated by TACE.

After transplantation, the safety and efficacy will be evaluated every 6 and 12 weeks, respectively, until intolerable toxicity, recurrence or up to 12 months treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.);

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Donafenib
0.2g BID for downstaging treatment; 0.1g BID for adjuvant therapy

Procedure:
• TACE
For downstaging treatment

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Downstaging success rate	Definition of successful downstaging: those who meet the UCSF standard with baseline AFP > 1000 ng/ml need to be reduced to < 500 ng/ml.	Immediately after downstaging treatment
Secondary	Objective response rate before transplantation (ORR)		1 year
Secondary	Complete pathological response rate (pCR)		1 year
Secondary	Recurrence-free survival (RFS)	Including median RFS, 1, 2, 3-years RFS rate	3 years
Secondary	Overall survival (OS)	Including median OS, 1, 2, 3-years OS rate	3 years
Secondary	Adverse events		3 years