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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donafenib + TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib combined with TACE | Drug | Donafenib(200mg bid po) combined with TACE |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | evaluated by investigators with mRECIST | an expected average of 12 months |
| Disease control rate | evaluated by investigators with mRECIST |
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Inclusion Criteria:
Exclusion Criteria:
Donafenib forbidden population:
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.
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Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minjie Yang, M.D., Ph.D. | Contact | 13122806500 | yang.minjie@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000710249 | donafenib |
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| an expected average of 12 months |
| 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 |
| Overall survival | The time from enrollment to the death from any cause | an expected average of 18 months |
| The incidence of AEs and SAEs by NCI-CTCAE v5.0 | Safety index | an expected average of 18 months |
| Conversion rate | Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy. | an expected average of 18 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |