Status:
UNKNOWN
A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hepatocellular Carcinoma
Donafenib
Eligibility:
All Genders
18+ years
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-ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05205629
Start Date
January 30 2022
End Date
March 30 2024
Last Update
March 23 2022
Active Locations (1)
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1
Fudan University
Shanghai, China