NCT05576909

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

July 13, 2023

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

August 14, 2022

Last Update Submit

July 11, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

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.

    Immediately after downstaging treatment

Secondary Outcomes (5)

  • Objective response rate before transplantation (ORR)

    1 year

  • Complete pathological response rate (pCR)

    1 year

  • Recurrence-free survival (RFS)

    3 years

  • Overall survival (OS)

    3 years

  • Adverse events

    3 years

Study Arms (1)

Donafenib

EXPERIMENTAL

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

Drug: DonafenibProcedure: TACE

Interventions

DonafenibDRUG

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

Donafenib
TACEPROCEDURE

For downstaging treatment

Donafenib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of HCC either by biopsy or according to AASLD criteria;
  • At least one measurable lesion according to mRECIST;
  • 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%;
  • Child-Pugh class ≤ 7;
  • ECOG Performance Status 0-1;
  • 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

You may not qualify if:

  • The pathological diagnosis was hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed type or fibrous lamellar hepatocellular carcinoma;
  • There were inferior vena cava cancer thrombus, hepatic vein cancer thrombus, regional lymph node invasion or extrahepatic metastasis;
  • HCC recurred within 2 years after radical resection or ablation;
  • 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;
  • 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;
  • There are contraindications to TACE determined by the investigators (e.g., portal vein trunk obstruction without formation of collateral vessels, etc.);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Lu Qian

CONTACT

15810088530luqianbtch@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

October 13, 2022

Study Start

March 30, 2023

Primary Completion

October 15, 2024

Study Completion

October 15, 2025

Last Updated

July 13, 2023

Record last verified: 2022-08

Locations

CN(1)