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

NCT ID: NCT05576909

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2025-10-15

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donafenib

Donafenib combine with TACE for downstaging treatment;

Donafenib for adjuvant therapy.

Group Type: EXPERIMENTAL

Donafenib

Intervention Type: DRUG

0.2g BID for downstaging treatment;

0.1g BID for adjuvant therapy

TACE

Intervention Type: PROCEDURE

For downstaging treatment

Interventions

Donafenib

0.2g BID for downstaging treatment;

0.1g BID for adjuvant therapy

Intervention Type: DRUG

TACE

For downstaging treatment

Intervention Type: PROCEDURE

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.);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Qian

Role: CONTACT

luqianbtch@163.com

15810088530

Facility Contacts

Lu Qian

Role: primary

Other Identifiers

DPM-HCC-N03

Identifier Type: -

Identifier Source: org_study_id