Hepatocellular CarcinomaPhase 2NCT04157140
Anlotinib In Combination With RFA And TACE in Patients With Middle-advanced HCC
A Phase 2 study testing Anlotinib and TACE+RFA in people with Hepatocellular Carcinoma, run by Jinglong Chen at 3 sites in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Anlotinib and TACE+RFA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesChina
- Study dates
- 28 Nov 2019to 30 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100011
Xiaoyan Ding, M.D., 13811560276 ext. +86, dingxiaoyan198111@163.com
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Feng Wang
- Not yet recruiting
Shengjing Hospital Of China Medical University
Shenyang
Zaiming Lu
About this study
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
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)
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anlotinib, TACE+RFA
- Keywords
- anlotinib, HCC, TACE, RFA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
TACE+RFADevice
TACE first, followed by RFA within day7（+/-3days）
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+ TACE+ RFA | Experimental | Anlotinib+ TACE+ RFA Receives: Drug: Anlotinib; Device: TACE+RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression(TTP)
Time To Progression is defined as the time from first day of TACE treatment until the first date of either objective disease progression
Measured: each 42 days up to progressive disease (PD) (up to 24 months)
Secondary outcomes (4)
Objective Response Rate (ORR)
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).
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the mRECIST.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Duration of Response (DOR)
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.
Measured: Time Frame: each 42 days up to intolerance the PD or death (up to 24 months)
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start28 Nov 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinglong Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinglong Chen, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157140
- Sponsor's protocol ID
- 320.6750.19089-49
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04157140
- Acronym / sponsor ID
- 320.6750.19089-49
- Conditions
- Hepatocellular Carcinoma
- Keywords
- anlotinib, HCC, TACE, RFA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jinglong ChenUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+ TACE+ RFA | Experimental | Drug: Anlotinib, Device: TACE+RFAAnlotinib+ TACE+ RFA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%)
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle. | Drug | Anlotinib+ TACE+ RFA |
| TACE+RFATACE first, followed by RFA within day7（+/-3days） | Device | Anlotinib+ TACE+ RFA |
Primary outcome
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
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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)
Duration of Response (DOR)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and TACE+RFA in people with Hepatocellular Carcinoma, run by Jinglong Chen at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XiaoYan Ding, M.D (13811560276 ext. +86, dingxiaoyan198111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Progression(TTP) (time frame: each 42 days up to progressive disease (PD) (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.