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| Name | Class |
|---|---|
| Suzhou Zelgen Biopharmaceuticals Co.,Ltd | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of the combination of donafenib and TACE in the perioperative period of liver transplantation.
This study plans to enroll about 20 patients with hepatocellular carcinoma (HCC) who do not meet the UCSF standard, they will receive donafenib combined with TACE in downstaging period and donafenib only in adjuvant period.
Before the liver transplantation, the safety and efficacy will be evaluated every 3 and 6 weeks, respectively, until liver transplantation or the disease progression that couldn't be treated by TACE.
After transplantation, the safety and efficacy will be evaluated every 6 and 12 weeks, respectively, until intolerable toxicity, recurrence or up to 12 months treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donafenib | Experimental | Donafenib combine with TACE for downstaging treatment; Donafenib for adjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donafenib | Drug | 0.2g BID for downstaging treatment; 0.1g BID for adjuvant therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Downstaging success rate | Definition of successful downstaging: those who meet the UCSF standard with baseline AFP > 1000 ng/ml need to be reduced to < 500 ng/ml. | Immediately after downstaging treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate before transplantation (ORR) | 1 year | |
| Complete pathological response rate (pCR) | 1 year | |
| Recurrence-free survival (RFS) |
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Inclusion Criteria:
Diagnosis of HCC either by biopsy or according to AASLD criteria;
At least one measurable lesion according to mRECIST;
The previous palliative TACE treatment did not exceed one time, with an interval of ≥ 6 months; For patients who had received one prior TACE treatment, the treated lession progressed or lipiodol deposition was less than 50%;
Child-Pugh class ≤ 7;
ECOG Performance Status 0-1;
Intrahepatic tumors meet any of the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Qian | Contact | 15810088530 | luqianbtch@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | 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 |
For downstaging treatment |
|
Including median RFS, 1, 2, 3-years RFS rate |
| 3 years |
| Overall survival (OS) | Including median OS, 1, 2, 3-years OS rate | 3 years |
| Adverse events | 3 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |