TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT
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- STATUS
- Recruiting
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- End date
- Jan 8, 2025
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- participants needed
- 171
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- sponsor
- Second Affiliated Hospital of Guangzhou Medical University
Summary
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with sorafenib/lenvatinib and iodion-125 seeds brachytherapy (TACE-MKI-I) compared with TACE combined with sorafenib/lenvatinib (TACE-MKI) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
Description
This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-MKI-I compared with TACE-MKI for the treatment of HCC with branch PVTT.
171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-MKI-I or TACE-MKI using an 2:1 randomization scheme.
TACE will be performed for the patients after randomization. Either sorafenib (400mg P.O. BID) or lenvatinib (body weight 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE according to the patients' own will and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-MKI-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Details
| Condition | Hepatocellular Carcinoma Non-resectable |
|---|---|
| Treatment | TACE combined with sorafenib/lenvatinib and iodion-125 seeds brachytherapy, TACE combined with sorafenib/lenvatinib |
| Clinical Study Identifier | NCT04967495 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Last Modified on | 13 August 2021 |
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