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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205629
• Other study ID #: B2021-640R
• Status: Recruiting
• Start date: January 30, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Minjie Yang, M.D., Ph.D.
• Phone: 13122806500
• Email: yang.minjie[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Donafenib combined with TACE
Donafenib(200mg bid po) combined with TACE

Locations

Country	Name	City	State
China	Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate	evaluated by investigators with mRECIST	an expected average of 12 months
Secondary	Disease control rate	evaluated by investigators with mRECIST	an expected average of 12 months
Secondary	Time to untreatable progression	It is defined as the time when a tumor that cannot be treated by TACE progresses, deteriorates to Child-pugh C, or appears extrahepatic metastasis.	an expected average of 12 months
Secondary	Overall survival	The time from enrollment to the death from any cause	an expected average of 18 months
Secondary	The incidence of AEs and SAEs by NCI-CTCAE v5.0	Safety index	an expected average of 18 months
Secondary	Conversion rate	Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy.	an expected average of 18 months