ClinicalTrials.gg
Status unknownNCT05576909Updated Jul 13, 2023

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

A Phase 2 interventional study of Donafenib and TACE in Hepatocellular Carcinoma, sponsored by Beijing Tsinghua Chang Gung Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 102 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.);
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Donafenib

    Donafenib combine with TACE for downstaging treatment; Donafenib for adjuvant therapy.

    Drug: Donafenib · Procedure: TACE

Interventions

  • 0.2g BID for downstaging treatment; 0.1g BID for adjuvant therapy

  • ProcedureTACE

    For downstaging treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after downstaging treatment

Secondary outcomes

  1. Objective response rate before transplantation (ORR)

    Time frame: 1 year

  2. Complete pathological response rate (pCR)

    Time frame: 1 year

  3. Recurrence-free survival (RFS)

    Including median RFS, 1, 2, 3-years RFS rate

    Time frame: 3 years

  4. Overall survival (OS)

    Including median OS, 1, 2, 3-years OS rate

    Time frame: 3 years

  5. Adverse events

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Tsinghua Changgung Hospital
    Beijing, China
    • Lu Qian · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05576909
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Mar 30, 2023
Primary completion
Oct 15, 2024 (estimated)
Completion
Oct 15, 2025 (estimated)
Last update
Jul 13, 2023

Study contacts

Lu Qian
Contact
luqianbtch@163.com
15810088530

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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