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

• Conditions: Hepatocellular Carcinoma; Donafenib
• Interventions: Drug: Donafenib combined with TACE

• Registration Number: NCT05205629
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-01-30
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23
• Primary Completion: 2024-01-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Donafenib + TACE	Donafenib combined with TACE	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	an expected average of 8 months	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	an expected average of 12 months	evaluated by investigators with mRECIST
Overall survival	an expected average of 18 months	The time from enrollment to the death from any cause
The incidence of AEs and SAEs by NCI-CTCAE v5.0	an expected average of 18 months	Safety index
Disease control rate	an expected average of 12 months	evaluated by investigators with mRECIST
Time to untreatable progression	an expected average of 12 months	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.
Conversion rate	an expected average of 18 months	Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy.

Trial Locations

Locations (1)

Fudan University; 🇨🇳 Shanghai, China