Last updated: March 21, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Abdominal Cancer
Liver Cancer
Cancer/tumors
Treatment
N/AClinical Study ID
NCT05205629
B2021-640R
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thosepatients 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 withdonafenib in combination with TACE.
Exclusion
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 ofthe 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 weeksprior to initial dosing;
- Pregnant or breastfeeding women, and women or men with fertility who are unwilling orunable 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.
Study Design
Total Participants: 150
Study Start date:
January 30, 2022
Estimated Completion Date:
March 30, 2024
Connect with a study center
Fudan University
Shanghai,
ChinaActive - Recruiting

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