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This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donafenib | Experimental | Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib, PD-1 | Drug | Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival 1(PFS 1) | PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause. | an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per mRECIST | The proportion of patients exhibiting a complete response or partial response to treatment, as assessed by mRECIST. | an average of 1 year |
| Disease control rate (DCR) per mRECIST |
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Inclusion Criteria:
Patients voluntarily enter the study and sign informed consent form (ICF);
Age ≥ 18 years and ≤ 75 years, 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);
ECOG : 0 ~ 1 ;
The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;
Previous TACE treatment ≤ 1 time;
Life expectancy ≥ 3 months;
For patients with HBV infection, if HBV-DNA is≥10^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to <10^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;
Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:
Blood routine examination criteria must be met: (no blood transfusion within 14 days)
Biochemical tests are subject to the following criteria:
Blood coagulation indexes are subject to the following criteria:
The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, M.D., Ph.D. | Zhongshan Hospital, Fudan University, Shanghai, China. | Principal Investigator |
| Zhiping Yan, M.D., Ph.D. | Zhongshan Hospital, Fudan University, Shanghai, China. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University, | Shanghai | Shanghai Municipality | 200032 | 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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| TACE | Procedure | TACE will be performed by the investigator based on the patient's tumor status. |
|
The proportion of patients exhibiting a complete response, partial response or stable disease, as assessed by mRECIST.
| an average of 1 year |
| Overall survival (OS) | The time from the date of enrollment to the date of death from any cause. | an average of 1.5 year |
| Adverse events and serious adverse events. | Incidence of adverse events and serious adverse events. | an average of 1.5 year. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |