The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study

NCT07180459 | Not Yet Recruiting

• 1 other identifier: 2025-KY-1085-002
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 10

Brief Summary

To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.

Conditions

Carcinoma; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  The definition of PFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.

  up to 1 year

Secondary Outcomes (4)

• ORR

  up to 1 year

• OS

  up to1 year

• TTP

  up to1 year

• AE

  up to1 year

Study Arms (1)

E-TACE in Combination with Donafenib

Procedure: E-TACE; Drug: Donafenib

Interventions

E-TACE PROCEDURE

The 70/100μm drug-loaded microspheres were loaded with anthracyclines (30mg-50mg Idarubicin) at 2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded anthracyclines (30mg-50mg Idarubicin) with 2mL/3mLto embolize the tumor supplying arteries at different grades and diameters.

E-TACE in Combination with Donafenib

Donafenib DRUG

400mg QD

E-TACE in Combination with Donafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

118 Hepatocellular carcinoma Patients

You may qualify if:

• (1) Patients with unresectable primary liver cancer who strictly meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2024 Edition) or who have been diagnosed through pathological histology or cytology examination, and who have at least one measurable lesion (according to the mRECIST 1.1 version, the long diameter of the measurable lesion on spiral CT scan should be ≥ 10mm or the short diameter of the enlarged lymph node should be ≥ 15mm); (2) Tumor staging: CNLC stage Ib, IIa, IIb, IIIa, IIIb or BCLC A, B, C stage; non-diffuse liver cancer (PVTT classified according to the Japanese Liver Cancer Research Society's portal vein tumor thrombus characteristics as Vp1/2, Vp3, Vp4); (3) Gender of the patients is not restricted, and the age is 18-80 years old; expected lifespan is ≥ 3 months; (4) Within 1 week before enrollment, the ECOG PS score: 0-1; (5) No severe comorbidities, such as hypertension, coronary heart disease and history of mental illness, no severe allergy history; (6) Liver function should reach Child-Pugh grade A or B; (7) Laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L); serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine shows urine protein \< 2+; for patients whose urine protein ≥ 2+ at baseline, 24-hour urine collection should be conducted and the 24-hour urine protein quantification \< 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; (8) HBV DNA \< 2000 IU/ml (104 copies/ml); (9) For pregnant women of childbearing age, a pregnancy test should be conducted within 7 days before enrollment; (10) Patients have signed the informed consent form agreeing to participate in this trial study; good compliance and cooperation with treatment.

Sponsors & Collaborators

• Xuhua Duan: lead

Study Sites (10)

People's Hospital of Kaiyang County

Guiyang, Guizhou, China

Location

The Second Affiliated Hospital of Hainan Medical Universsity

Haikou, Hainan, China

Location

Huai He Hospital of Henan University

Kaifeng, Henan, China

Location

Luo He Central Hospital

Luohe, Henan, China

Location

Luo Yang Central Hospital

Luoyang, Henan, China

Location

Deng zhou People's Hospital

Nanyang, Henan, China

Location

First People's Hospital of Shangqiu

Shangqiu, Henan, China

Location

Zhou Kou Central Hospital

Zhoukou, Henan, China

Location

Jiangxi Provincial People's Hospitail

Nanchang, Jiangxi, China

Location

Second People's Hospital of Jiaozuo

Jiaozuo, China

Location

MeSH Terms

Conditions

Carcinoma; Carcinoma, Hepatocellular

Interventions

donafenib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Xuhua Duan Duan

CONTACT

+86 13523402912; xuhuaduan@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (10)