A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC

A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma

This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Donafenib
• Intervention / Treatment: Drug: Donafenib combined with TACE

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Minjie Yang, M.D., Ph.D.; Phone Number: 13122806500; Email: yang.minjie@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University
    • Contact: Minjie Yang, M.D., Ph.D.; Phone Number: 13122806500; Email: yang.minjie@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.

Description

Inclusion Criteria:

1. Patients voluntarily entered the study and signed informed consent form (ICF);
2. Age: Be at least 18 years old and and there is no limit on the gender;
3. Clinically or histologically diagnosed as unresectable HCC;
4. There is at least one measurable lesions that meet the mRECIST standard;
5. Child-pugh classification A or B (score≤7);
6. The maximum number of TACE procedures allowed before enrolment was 2. All of those patients who had a history of prior TACE achieved complete response by previous TACE, but recurred more than 6 months later at the study entry
7. ECOG : 0 ~ 2 ;
8. Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE.

Exclusion Criteria:

1. Donafenib forbidden population:

   • Those who are allergic to any component of the medicine;
   • Active bleeding;
   • Active peptic ulcer;
   • Hypertension not controlled by drugs;
   • Those with severe liver insufficiency.
2. Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
3. Patients with a clear past history of neurological or psychiatric disorders;
4. The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
5. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
6. Unable to follow the research protocol for treatment or scheduled follow-up;
7. Any other researcher who thinks they cannot be included.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Donafenib + TACE	Drug: Donafenib combined with TACE; Donafenib(200mg bid po) combined with TACE; Other Names: Donafenib plus TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.	an expected average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	evaluated by investigators with mRECIST	an expected average of 12 months
Disease control rate	evaluated by investigators with mRECIST	an expected average of 12 months
Time to untreatable progression	It is defined as the time when a tumor that cannot be treated by TACE progresses, deteriorates to Child-pugh C, or appears extrahepatic metastasis.	an expected average of 12 months
Overall survival	The time from enrollment to the death from any cause	an expected average of 18 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0	Safety index	an expected average of 18 months
Conversion rate	Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy.	an expected average of 18 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Anticipated): January 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: B2021-640R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No