Hepatocellular CarcinomaPhase 2ALTER-H-004NCT04213118
Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence
A Phase 2 study testing Anlotinib Hydrochloride and TACE in people with Hepatocellular Carcinoma and TACE, run by First Affiliated Hospital Xi'an Jiaotong University at 4 sites in China.
Trial summary
A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(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, TACE, Anlotinib
- What is being tested?
- Anlotinib Hydrochloride and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 23 Apr 2020to Sep 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.
- After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
- Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP > 400μg/L.
- TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
- ≥ 18 and ≤ 75 years of age.
- ECOG performance status of 0-1.
- liver function child-Pugh class A or B (≤7 points).
- Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function.
Who cannot join
- Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE.
- Patients with absolute contraindications to TACE.
- Patients with HCV infection.
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed.
- Pregnant or lactating women.
- Patients with mental illness.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Tangdu Hospital of The Fourth Military Medical University
Xi'an, Shaanxi, 710000
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
Official title: An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(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 adopt postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD PO d1-14, 21 days per cycle until disease progresses or intolerant.
Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
- Conditions
- Hepatocellular Carcinoma, TACE, Anlotinib
- Being tested
- Anlotinib Hydrochloride, TACE
- 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.
TACEProcedure or surgery
TACE first, followed by anlotinib within day4（+/-1days）
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent. Receives: Drug: Anlotinib Hydrochloride; Procedure: TACE |
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 (3)
1-year DFS Rate
One year ratio of DFS
Measured: From randomization to recurrence of HCC or death (up to 1year)
Time to recurrence
The period from resection surgery to recurrence of HCC
Measured: From randomization to recurrence of HCC(up to 1year)
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Any adverse effects occur during the use of anlotinib
Measured: Up to 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 posted30 Dec 2019
- Study start23 Apr 2020
- Primary completionFeb 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zheng Wu, PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213118
- Sponsor's protocol ID
- KYLLSL-2019-185
- Acronym
- ALTER-H-004
- Status last verified
- Nov 2022
- First submitted
- 25 Dec 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Z, Zhang L, Zheng X, Zhang D, Yang X, Xu K, Tao J, Song X, Ma J, Wu Z. Adjuvant anlotinib plus TACE in hepatocellular carcinoma with postoperative high-risk recurrence: a single-arm, multi-center, phase II study. Clin Transl Oncol. 2026 Jun;28(6):2198-2207. doi: 10.1007/s12094-025-04160-0. Epub 2026 Jan 3.
PubMed 41484570
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04213118
- Acronym / sponsor ID
- ALTER-H-004 / KYLLSL-2019-185
- Conditions
- Hepatocellular Carcinoma, TACE, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 30 Dec 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 to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(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 adopt postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD PO d1-14, 21 days per cycle until disease progresses or intolerant.
Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Anlotinib Hydrochloride, Procedure: TACEAdministration 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 (8 listed)
- Patients participate in the study voluntarily and sign informed consent with good compliance.
- After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
- Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP > 400μg/L.
- TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
- ≥ 18 and ≤ 75 years of age.
Key exclusion criteria (6 listed)
- Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE.
- Patients with absolute contraindications to TACE.
- Patients with HCV infection.
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed.
- Pregnant or lactating women.
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. | Drug | Group A |
| TACETACE first, followed by anlotinib within day4（+/-1days） | Procedure or surgery | Group A |
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
3 secondary outcomes
1-year DFS Rate
Time frame: From randomization to recurrence of HCC or death (up to 1year)
Time to recurrence
Time frame: From randomization to recurrence of HCC(up to 1year)
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Time frame: Up to 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 17 Jan 2023.
- Derived from this study: PubMed 41484570Wang Z, Zhang L, Zheng X, Zhang D, Yang X, Xu K, Tao J, Song X, Ma J, Wu Z. Adjuvant anlotinib plus TACE in hepatocellular carcinoma with postoperative high-risk recurrence: a single-arm, multi-center, phase II study. Clin Transl Oncol. 2026 Jun;28(6):2198-2207. doi: 10.1007/s12094-025-04160-0. Epub 2026 Jan 3.
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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.
Zheng Wu, PhD study chair
First Affiliated Hospital Xi'an Jiaotong University
4 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 Hydrochloride and TACE in people with Hepatocellular Carcinoma and TACE, run by First Affiliated Hospital Xi'an Jiaotong University at 4 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 6 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
On the ClinicalTrials.gov record for NCT04213118, which also lists 1 linked publication.
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 17 Jan 2023.