Clinical trial · Interventional
Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation
Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation: a Single-arm Exploratory Study
NCT05576909CI-TRIAL-00067969unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Donafenib
- description
- Donafenib combine with TACE for downstaging treatment; Donafenib for adjuvant therapy.
- interventionNames
- Drug: Donafenib
- Procedure: TACE
Primary outcomes (1)
- measure
- Downstaging success rate
- timeFrame
- Immediately after downstaging treatment
- description
- Definition of successful downstaging: those who meet the UCSF standard with baseline AFP \> 1000 ng/ml need to be reduced to \< 500 ng/ml.
Secondary outcomes (5)
- measure
- Objective response rate before transplantation (ORR)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.);
References
Publications (0)
Data not yet available
No reference posted for this study.