Hepatocellular CarcinomaPhase 1/2NCT03945799
A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
A Phase 1/2 study testing Anlotinib Hydrochloride in people with Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence. 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 Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 25 Jun 2022
- Phase
- Phase 1/2
- 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
- No allergic history of Anlotinib
- 18-75 years
- No history of severe arrhythmia or heart failure
- No history of severe ventilation dysfunction or severe pulmonary infection
- No acute or chronic renal failure, creatinine clearance > 40 mL/min
- Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
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- Blood test: the absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10^9 /L (without blood transfusions and drug therapy 14 days before the screening)
- Blood coagulation function: INR≤2.3
- ECOG: 0-2
- Pathology: hepatocellular carcinoma
- Satisfy any of the following:
- portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
- Patients participate in the study voluntarily and sign informed consent
Who cannot join
- Pregnant or lactating women
- Patients who have had or are currently complicated with other malignant tumors
- Recurrent hepatocellular carcinoma
- Patients who participated in other clinical trials within 1 month
- Patients with mental illness
- Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
Read the detailed description
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. HCC patients who meet the eligibility criteria of this clinical trial will be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Anlotinib Hydrochloride
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent. Receives: Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
The period from resection surgery to recurrence of HCC
Measured: From randomization to recurrence of HCC or death (up to 1year)
Secondary outcomes (2)
Adverse effect
Any adverse effects occur during the use of anlotinib
Measured: Up to 1year
Overall survival
The survival rate in a year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start22 Apr 2019
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Why it stopped: The study has gotten preliminary results and stopped advanced.
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 Zhejiang UniversityThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945799
- Sponsor's protocol ID
- KY2019-AHR-ZJU
- Status last verified
- Aug 2022
- First submitted
- 9 May 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.
- ClinicalTrials.gov ID
- NCT03945799
- Acronym / sponsor ID
- KY2019-AHR-ZJU
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has gotten preliminary results and stopped advanced.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 10 May 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.
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
Detailed description
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. HCC patients who meet the eligibility criteria of this clinical trial will be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: Anlotinib HydrochlorideAdministration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- No allergic history of Anlotinib
- 18-75 years
- No history of severe arrhythmia or heart failure
- No history of severe ventilation dysfunction or severe pulmonary infection
- No acute or chronic renal failure, creatinine clearance > 40 mL/min
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Patients who have had or are currently complicated with other malignant tumors
- Recurrent hepatocellular carcinoma
- Patients who participated in other clinical trials within 1 month
- Patients with mental illness
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 |
|---|---|---|
| Anlotinib HydrochlorideAnlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles. | Drug | Anlotinib |
Primary outcome
Disease free survival
Time frame: From randomization to recurrence of HCC or death (up to 1year)
The period from resection surgery to recurrence of HCC
2 secondary outcomes
Adverse effect
Time frame: Up to 1year
Overall survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The study has gotten preliminary results and stopped advanced.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anlotinib Hydrochloride in people with Hepatocellular Carcinoma, run by Zhejiang University 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Aug 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: The study has gotten preliminary results and stopped advanced.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From randomization to recurrence of HCC or death (up to 1year)). 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 31 Aug 2022.