Hepatocellular CarcinomaPhase 2ALTER-H-002NCT04080154
Study of Anlotinib After Lenvatinib in Patients With Hepatocellular Carcinoma
A Phase 2 study testing Anlotinib in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This clinical study evaluates the efficacy and safety of anlotinib in patients with hepatocellular carcinoma who have progressed on lenvatinib treatment. It is a single arm, open-label clinical trial conducted in China, and plan to recruit 28 patients. Primary endpoint of the study is Progress Free Survival. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2019to Oct 2021
- 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.
- Histological or cytological confirmation of hepatocellular carcinoma (HCC) or non-invasive diagnosis of HCC as per Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition).
- Barcelona Clinic Liver Cancer stage Category C or B that cannot benefit from local treatment.
- Liver function status Child-Pugh Class A or Class B (≤7 points).
- Failure to prior treatment with lenvatinib according to the RECIST1.1. The last dose of lenvatinib should be over 2 weeks and within 10 weeks before the first dose of anlotinib.
- At least one measurable lesion according to the RECIST1.1.
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- 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, Platelet count (PLT) ≥ 60×109/L, Albumin≥ 28g/L, Total bilirubin (TBIL) ≤ 2.0 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN, Hepatitis B virus DNA (HBV-DNA)<1000copy/ml.)
- 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 6 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 6 months after it.
Who cannot join
- Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms).
- Liver function status Child-Pugh Class C, with malignant ascites.
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than Common Terminology Criteria for Adverse Events (CTCAE) 3 grade within 4 weeks prior to enrollment.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Prior systemic treatment for HCC, except lenvatinib. Intolerance of lenvatinib (defined as not less than 20 days at a minimum daily dose of 400 mg within the last 28 days).
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- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Known history or symptomatic metastatic brain or meningeal tumors.
- 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.
- History of gastrointestinal bleeding due to severe gastroesophageal varices or definite tendency of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency due to other causes, such as active ulcer, ulcerative colitis, etc. Fecal occult blood ≥ ++.
- Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>16 s, Activated partial thromboplastin time (APTT) >48 s, Thrombin time (TT)>21 s, International normalized ratio (INR)>2, fibrinogen (FIB)<2 g/L.
- Patients who underwent major surgery within 4 weeks.
- Patients who have got non remissive toxic reactions derived from lenvatinib treatment, which is over level 2 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Qiman Sun contact
About this study
Official title: A Single Arm, Open-label Study of Anlotinib in Patients With Hepatocellular Carcinoma (HCC) After Lenvatinib
This clinical study evaluates the efficacy and safety of anlotinib in patients with hepatocellular carcinoma who have progressed on lenvatinib treatment. It is a single arm, open-label clinical trial conducted in China, and plan to recruit 28 patients. Primary endpoint of the study is Progress Free Survival.
Read the detailed description
Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling. The prime targets of anlotinib include receptor tyrosine kinases vascular endothelial growth factor receptor1 to 3 (VEGFR1-3), fibroblast growth factor receptor 1 to 4 (FGFR1-4), platelet-derived growth factor receptor α and β (PDGFR α, β), and stem cell factor receptor.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anlotinib
- 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 orally (p.o.) every day (qd) for 2 weeks of every 3 week cycle (i.e. 2 weeks on, 1 week off)
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Anlotinib p.o., qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival (PFS)
Progress free survival is defined as the time from first day of anlotinib treatment until the first date of either objective disease progression or death due to any cause, whichever occurs first.
Measured: each 42 days up to progressive disease (PD) or death (up to 24 months)
Secondary outcomes (4)
Overall Survival (OS)
Overall survival is defined as the time from first day of anlotinib treatment until the date of death due to any cause or the date of the last contact, at which the patients will be censored.
Measured: From first day of anlotinib treatment until death (up to 24 months)
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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1).
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 RECIST1.1.
Measured: each 42 days up to intolerance the toxicity or PD (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 posted6 Sep 2019
- Study start24 Sep 2019
- Primary completionFeb 2021 (estimated)
- Study completionOct 2021 (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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowu Huang, doctor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080154
- Sponsor's protocol ID
- B2019-173R
- Acronym
- ALTER-H-002
- Status last verified
- Apr 2020
- First submitted
- 3 Sep 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label Study of Anlotinib in Patients With Hepatocellular Carcinoma (HCC) After Lenvatinib
- ClinicalTrials.gov ID
- NCT04080154
- Acronym / sponsor ID
- ALTER-H-002 / B2019-173R
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Sep 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.
This clinical study evaluates the efficacy and safety of anlotinib in patients with hepatocellular carcinoma who have progressed on lenvatinib treatment. It is a single arm, open-label clinical trial conducted in China, and plan to recruit 28 patients. Primary endpoint of the study is Progress Free Survival.
Detailed description
Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling. The prime targets of anlotinib include receptor tyrosine kinases vascular endothelial growth factor receptor1 to 3 (VEGFR1-3), fibroblast growth factor receptor 1 to 4 (FGFR1-4), platelet-derived growth factor receptor α and β (PDGFR α, β), and stem cell factor receptor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibAnlotinib p.o., qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients participate in the study voluntarily and sign informed consent.
- Histological or cytological confirmation of hepatocellular carcinoma (HCC) or non-invasive diagnosis of HCC as per Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition).
- Barcelona Clinic Liver Cancer stage Category C or B that cannot benefit from local treatment.
- Liver function status Child-Pugh Class A or Class B (≤7 points).
- Failure to prior treatment with lenvatinib according to the RECIST1.1. The last dose of lenvatinib should be over 2 weeks and within 10 weeks before the first dose of anlotinib.
Key exclusion criteria (18 listed)
- Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms).
- Liver function status Child-Pugh Class C, with malignant ascites.
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than Common Terminology Criteria for Adverse Events (CTCAE) 3 grade within 4 weeks prior to enrollment.
- Participated in other anti-tumor clinical trials 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 orally (p.o.) every day (qd) for 2 weeks of every 3 week cycle (i.e. 2 weeks on, 1 week off) | Drug | Anlotinib |
Primary outcome
Progress free survival (PFS)
Time frame: each 42 days up to progressive disease (PD) or death (up to 24 months)
Progress free survival is defined as the time from first day of anlotinib treatment until the first date of either objective disease progression or death due to any cause, whichever occurs first.
4 secondary outcomes
Overall Survival (OS)
Time frame: From first day of anlotinib treatment until death (up to 24 months)
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)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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 Apr 2020.
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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.
Qiman Sun contact
Xiaowu Huang, doctor principal investigator
Shanghai Zhongshan Hospital
1 site 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 in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site 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 9 inclusion and 18 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiaowu Huang, doctor (86-21-60268618, huang.xiaowu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (PFS) (time frame: each 42 days up to progressive disease (PD) or death (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 Apr 2020.