Clinical trial NCT05205629: A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC
Official title: A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Donafenib
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: an expected average of 8 months
Secondary outcomes:
measure: Objective response rate
timeFrame: an expected average of 12 months
measure: Disease control rate
timeFrame: an expected average of 12 months
measure: Time to untreatable progression
timeFrame: an expected average of 12 months
measure: Overall survival
timeFrame: an expected average of 18 months
measure: The incidence of AEs and SAEs by NCI-CTCAE v5.0
timeFrame: an expected average of 18 months
measure: Conversion rate
timeFrame: an expected average of 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
Study officials:
References: