- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157140
Anlotinib In Combination With RFA And TACE in Patients With Middle-advanced HCC
November 30, 2019 updated by: Jinglong Chen
Anlotinib Hydrochloride In Combination With Radiofrequency Ablation And Transcatheter Arterial Chemoembolization in Patients With Middle-advanced Hepatocellular Carcinoma, Open, Single Arm, Exploratory Clinical Trial
A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with radiofrequency ablation (RFA) and transcatheter arterial chemoembolization(TACE) in patients with middle-advanced hepatocellular carcinoma(HCC)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: XiaoYan Ding, M.D
- Phone Number: +86 13811560276
- Email: dingxiaoyan198111@163.com
Study Locations
-
-
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Dalian, China
- Not yet recruiting
- The first affiliated hospital of Dalian Medical University
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Shenyang, China
- Not yet recruiting
- Shengjing Hospital of China Medical University
-
Contact:
- Zaiming Lu
-
-
Beijing
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Beijing, Beijing, China, 100011
- Recruiting
- Beijing Ditan Hospital, Capital Medical University
-
Contact:
- Xiaoyan Ding, M.D.
- Phone Number: +86 13811560276
- Email: dingxiaoyan198111@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients participate in the study voluntarily and sign informed consent with good compliance.
- Histological or cytological confirmation of unrespectable middle-advanced hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage Category C or B , liver function child-Pugh class A or B (≤7 points).
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per mRECIST; have not received local therapies including but not limited to TACE, RFA, radiotherapy and cryosurgery.-Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Life expectancy of at least 3 months.
- Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L, Platelet count (PLT) ≥ 70×109/L, Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min,Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
- Patients have disease that is not amenable to potentially curative transplantation or ablation
- Patients who have characterization for targeted therapy treatment, but under poor economic conditions and cannot afford angiogenesis inhibitors recommended by current guidelines, including Lenvatinib, sorafenib, Cabozantinib, Ramolumab, regorafenib, etc.
Exclusion Criteria:
- History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms).
- Subject has obstacle in the function of major organs such as heart, lung, liver and kidney
- Patients who plan liver transplantation.
- Patients who had previously received treatment with target inhibitors or other immunotherapy against or chemotherapy
- Patients who had previously received treatment with TACE or or other local therapy or radiotherapy or Chinese medicine treatment within 4 weeks.
- Liver function status Child-Pugh Class C, with malignant ascites.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, nternational normalized ratio (INR)>1.5
- Patients who underwent major surgery within 4 weeks.
- Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
- Patients with any severe and/or unable to control diseases,including: Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥480ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g.
- Patients whose tumors had invaded important blood vessels by imaging or who, as determined by the researchers, were likely to invade important blood vessels during follow-up trial, resulting in fatal bleeding.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with Brain metastases.
- Patients with cancer thrombus involving whole the main portal vein.
- Female patients who are pregnant or breastfeeding.
- Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
- History of gastrointestinal bleeding due to severe gastroesophageal varices within 4 weeks.
- Severe active or uncontrolled infections.
- Patients who had serious adverse effect to Anlotinib.
- Patients who had serious adverse effect to iodinated contrast agent.
- Liver cirrhosis, hepatic decompensation, active hepatitis or chronic hepatitis which requires anti-viral treatment. Hepatitis C virus (HCV) antibody test shows positive and titer test shows amount of HCV exceeds upper limit of normal (ULN) after treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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each 42 days up to progressive disease (PD) (up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
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.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Duration of Response (DOR)
Time Frame: Time Frame: each 42 days up to intolerance the PD or death (up to 24 months)
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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.
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Time Frame: each 42 days up to intolerance the PD or death (up to 24 months)
|
Incidence of Treatment-Emergent Adverse Events
Time Frame: Until 30 day safety follow-up visit
|
Safety and Tolerability
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Until 30 day safety follow-up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2019
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
March 30, 2023
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 8, 2019
Study Record Updates
Last Update Posted (Actual)
December 3, 2019
Last Update Submitted That Met QC Criteria
November 30, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 320.6750.19089-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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