Anlotinib In Combination With RFA And TACE in Patients With Middle-advanced HCC
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|ClinicalTrials.gov Identifier: NCT04157140|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Anlotinib Device: TACE+RFA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anlotinib Hydrochloride In Combination With Radiofrequency Ablation And Transcatheter Arterial Chemoembolization in Patients With Middle-advanced Hepatocellular Carcinoma, Open, Single Arm, Exploratory Clinical Trial|
|Estimated Study Start Date :||November 28, 2019|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: Anlotinib+ TACE+ RFA
Anlotinib+ TACE+ RFA
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
TACE first, followed by RFA within day7（+/-3days）
- Time To Progression(TTP) [ Time Frame: each 42 days up to progressive disease (PD) (up to 24 months) ]Time To Progression is defined as the time from first day of TACE treatment until the first date of either objective disease progression
- Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Modified Response Evaluation Criteria in Solid Tumors Version (mRECIST).
- Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the mRECIST.
- Duration of Response (DOR) [ Time Frame: Time Frame: each 42 days up to intolerance the PD or death (up to 24 months) ]Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the mRECIST or death due to any cause, whichever occurs first.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Until 30 day safety follow-up visit ]Safety and Tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157140
|Contact: XiaoYan Ding, M.D||13811560276 ext +email@example.com|
|Beijing Ditan Hospital, Capital Medical University|
|Beijing, Beijing, China, 100011|
|The First Affiliated Hospital of Dalian Medical University||Not yet recruiting|
|Contact: Feng Wang|
|Shengjing Hospital Of China Medical University||Not yet recruiting|
|Contact: Zaiming Lu|