NCT05205629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 23, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 23, 2021

Last Update Submit

March 21, 2022

Conditions

Hepatocellular CarcinomaDonafenib

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.

    an expected average of 8 months

Secondary Outcomes (6)

  • Objective response rate

    an expected average of 12 months

  • Disease control rate

    an expected average of 12 months

  • Time to untreatable progression

    an expected average of 12 months

  • Overall survival

    an expected average of 18 months

  • The incidence of AEs and SAEs by NCI-CTCAE v5.0

    an expected average of 18 months

  • +1 more secondary outcomes

Study Arms (1)

Donafenib + TACE

Drug: Donafenib combined with TACE

Interventions

Donafenib combined with TACEDRUG

Donafenib(200mg bid po) combined with TACE

Also known as: Donafenib plus TACE
Donafenib + TACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Minjie Yang, M.D., Ph.D.

CONTACT

13122806500yang.minjie@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 25, 2022

Study Start

January 30, 2022

Primary Completion

January 30, 2024

Study Completion

March 30, 2024

Last Updated

March 23, 2022

Record last verified: 2022-01

Locations

CN(1)