Donafenib, Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGDonafenib combined with TACE
Donafenib(200mg bid po) combined with TACE
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Objective response rate | an expected average of 12 months | evaluated by investigators with mRECIST |
| The incidence of AEs and SAEs by NCI-CTCAE v5.0 | an expected average of 18 months | Safety index |
| Conversion rate | an expected average of 18 months | Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy. |
| Overall survival | an expected average of 18 months | The time from enrollment to the death from any cause |
Countries
China
Contacts
Primary ContactMinjie Yang, M.D., Ph.D.
Outcome results
None listed