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

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/A

Clinical Study ID

NCT05205629
B2021-640R
  • Ages > 18
  • All Genders

Study 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

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 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
  7. ECOG : 0 ~ 2 ;
  8. Before the patients were enrolled in the study, doctors had decided to treat them withdonafenib in combination with TACE.

Exclusion

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.
  1. Medical conditions that affect absorption, distribution, metabolism, or clearance ofthe study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction,absorption disorders, etc.);
  2. Patients with a clear past history of neurological or psychiatric disorders;
  3. The patient had been treated with another study drug or study device in the 4 weeksprior to initial dosing;
  4. Pregnant or breastfeeding women, and women or men with fertility who are unwilling orunable to take effective contraceptive measures;
  5. Unable to follow the research protocol for treatment or scheduled follow-up;
  6. 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,
    China

    Active - Recruiting

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