A Phase 2 interventional study of Donafenib and TACE in Hepatocellular Carcinoma, sponsored by Beijing Tsinghua Chang Gung Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 2, Interventional, and Treatment
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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 102 studies on the registry; 52 are open to participants now.
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Intrahepatic tumors meet any of the following conditions:
Exclusion Criteria:
Donafenib combine with TACE for downstaging treatment; Donafenib for adjuvant therapy.
Drug: Donafenib · Procedure: TACE
0.2g BID for downstaging treatment; 0.1g BID for adjuvant therapy
For downstaging treatment
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.
Time frame: Immediately after downstaging treatment
Objective response rate before transplantation (ORR)
Time frame: 1 year
Complete pathological response rate (pCR)
Time frame: 1 year
Recurrence-free survival (RFS)
Including median RFS, 1, 2, 3-years RFS rate
Time frame: 3 years
Overall survival (OS)
Including median OS, 1, 2, 3-years OS rate
Time frame: 3 years
Adverse events
Time frame: 3 years
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donafenib
Beijing Tsinghua Chang Gung Hospital →