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

Fudan University

Status: Unknown

Conditions: Donafenib; Hepatocellular Carcinoma

Treatments: Drug: Donafenib combined with TACE

Study type: Observational

Funder types: Other

Identifiers

NCT05205629

B2021-640R

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Donafenib + TACE

Treatment:

Drug: Donafenib combined with TACE