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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma, Donafenib

Intervention / Treatment
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* Drug: Donafenib combined with TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients voluntarily entered the study and signed informed consent form (ICF); Age: Be at least 18 years old and and there is no limit on the gender; Clinically or histologically diagnosed as unresectable HCC; There is at least one measurable lesions that meet the mRECIST standard; Child-pugh classification A or B (score≤7); 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 ECOG : 0   2 ; Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE. Exclusion Criteria: 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. Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); Patients with a clear past history of neurological or psychiatric disorders; The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing; Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Donafenib + TACE<br> | Drug: Donafenib combined with TACE<br>* Donafenib(200mg bid po) combined with TACE<br>* Other names: Donafenib plus TACE;|

What is the study measuring?
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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 |