To hear about similar clinical trials, please enter your email below
Trial Title:
Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation
NCT ID:
NCT05576909
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Donafenib
Description:
0.2g BID for downstaging treatment;
0.1g BID for adjuvant therapy
Arm group label:
Donafenib
Intervention type:
Procedure
Intervention name:
TACE
Description:
For downstaging treatment
Arm group label:
Donafenib
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.
Detailed 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.
Criteria for 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.);
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tsinghua Changgung Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Qian
Start date:
March 30, 2023
Completion date:
October 15, 2025
Lead sponsor:
Agency:
Beijing Tsinghua Chang Gung Hospital
Agency class:
Other
Collaborator:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Beijing Tsinghua Chang Gung Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05576909
