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Unresectable Hepatocellular CarcinomaPhase 2ABH-uHCCNCT07806292

Anlotinib + Benmelstobart + HAIC in Unresectable HCC: A Phase II Study

A Phase 2 study testing anlotinib combined with benmelstobart and HAIC in people with Unresectable Hepatocellular Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy and safety of anlotinib combined with benmelstobart and HAIC as first-line treatment for unresectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
anlotinib combined with benmelstobart and HAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
28 Apr 2025to 28 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age between 18 and 75 years, regardless of gender.
  • Confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) according to both the China Liver Cancer (CNLC) staging criteria and the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.
  • At least one measurable lesion as defined by the following criteria: the longest diameter ≥ 10 mm for non-nodal lesions, or the short-axis diameter ≥ 15 mm for nodal lesions; confirmed unresectable HCC; Child-Pugh liver function score ≤ 7.
  • Naive to any local (ablation, hepatic arterial embolization/infusion therapy, liver transplantation) or systemic therapy (chemotherapy and/or molecular targeted therapy, immunotherapy; antiviral therapy excluded) for HCC at initial diagnosis, or patients with intrahepatic recurrence after previous radical resection.
  • Expected survival time ≥ 12 weeks.
  • No anti-HCC drugs (including modern traditional Chinese medicine preparations indicated for HCC: Lentinan Injection, Kanglaite Injection or Soft Capsules, Aidi or Kangsaidi Injection, Propaneed Oil, Huai'er Granules, and Ganfule Tablets) administered within 2 weeks prior to the first dose.
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  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • HBV DNA < 10^4 copies/ml (2000 IU/ml). If HBV DNA ≥ 10^4 copies/ml, antiviral therapy must be initiated first and continued until HBV DNA drops below 10^4 copies/ml before entering the study, along with ongoing antiviral medication and monitoring of liver function and HBV viral load.
  • Normal function of major organs, meeting the following criteria:
  • Hematology (no blood transfusion or G-CSF administered within 14 days prior to screening): i. Hemoglobin (Hb) ≥ 90 g/L; ii. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; iii. Platelet count (PLT) ≥ 75 × 10^9/L; b) Biochemistry (no albumin (ALB) administration within 14 days prior to testing): i. Albumin (ALB) ≥ 28 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5.0 × upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤ 4.0 × ULN (patients with obstructive jaundice may be enrolled after percutaneous transhepatic cholangial drainage (PTCD)); iv. Creatinine ≤ 1.5 × ULN; v. Electrolytes essentially normal or normalized after treatment. c) Urinalysis: i. Urine protein ≤ 1+.
  • The patient voluntarily consents to enrollment, signs the written informed consent form (ICF), and is able to comply with the required treatment and follow-up visits according to the protocol.

Who cannot join

  • Histologically confirmed fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma (HCC-ICC).
  • Symptomatic moderate to massive pleural effusion/ascites.
  • Obstructive jaundice, liver failure, or hepatic encephalopathy.
  • Patients with a second primary cancer or multiple malignancies, except for HCC, carcinoma in situ of the cervix, and non-melanoma skin cancer, or a history of other malignancies previously diagnosed and explicitly cured for at least 5 years with no evidence of subsequent recurrence.
  • Active bleeding or coagulation abnormalities (Prothrombin Time, PT > 16 s; Activated Partial Thromboplastin Time, APTT > 43 s; International Normalized Ratio, INR ≥ 2), bleeding tendency, or currently receiving thrombolytic, anticoagulant, or antiplatelet therapy.
  • Concomitant use of medications that may prolong the QTc interval and/or induce Torsades de Pointes (TdP), or affect the metabolism of chemotherapeutic agents.
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  • Pregnant or lactating women; sexually active men or women of childbearing potential who are unwilling or unable to use effective contraception.
  • Any significant clinical or laboratory abnormalities that, in the opinion of the investigator, would affect the safety evaluation, such as: uncontrolled active infection (> NCI-CTCAE v5.0 Grade 2), uncontrolled diabetes (> NCI-CTCAE v5.0 Grade 2), hypertension not controlled to below the specified range (systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg) despite treatment with two or more antihypertensive drugs, peripheral neuropathy ≥ Grade 2 (NCI-CTCAE v5.0), congestive heart failure ≥ Grade 2 (NCI-CTCAE v5.0), myocardial infarction within 6 months, or thyroid dysfunction (> NCI-CTCAE v5.0 Grade 2), etc.
  • History of brain metastases, subdural metastasis, or severe mental illness; patients suspected of central nervous system (CNS) metastases must be excluded by cranial MRI.
  • History of gastrointestinal bleeding or definite predisposition to gastrointestinal bleeding within the past 3 months, such as known active ulcer lesions, or fecal occult blood ≥ ++ (not eligible for enrollment); if persistent fecal occult blood is positive, a gastroscopy examination is required.
  • Severe gastric fundus/esophageal wall varices requiring interventional treatment.
  • Occurrence of abdominal or gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to the first dose.
  • Significant abnormality in glomerular filtration rate (estimated creatinine clearance < 60 ml/min or serum creatinine > 1.5 × ULN).
  • Active hepatitis C (i.e., anti-HCV positive or HCV-RNA positive with abnormal liver function); known history of HIV infection.
  • Receipt of other investigational drugs or medical devices within 4 weeks prior to the first dose; or prior use of anti-tumor indicated drugs where less than 2 weeks or 5 drug half-lives (whichever is longer) have elapsed between the completion of previous treatment and the administration of the study drug, and adverse events caused by prior treatment have not recovered to ≤ CTCAE Grade 1.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Changzhen Shang, M.D, PhD contact

+86-20-3407 0701

shchzh2@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

    Changzhen Shang, +86-20-3407 0701, shchzh2@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Phase II Clinical Study of Anlotinib Combined With Benmelstobart and HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma

To evaluate the efficacy and safety of anlotinib combined with benmelstobart and HAIC as first-line treatment for unresectable hepatocellular carcinoma.

Read the detailed description

A single-arm, multicenter, phase II investigator-initiated exploratory clinical study will be adopted to evaluate the efficacy and safety of anlotinib combined with benmelstobart and hepatic arterial infusion chemotherapy (HAIC) as first-line treatment for patients with unresectable advanced hepatocellular carcinoma (uHCC) meeting CNLC and AASLD diagnostic criteria and with no prior systemic therapy. Patients received HAIC with the FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² bolus plus 2400 mg/m² continuous infusion over 23 h) every 3 weeks for a maximum of 6 cycles, plus oral anlotinib 10 mg on days 1-14 (with permitted dose reduction to 8 mg for toxicity) and intravenous benmelstobart 1200 mg over 60 min on day 1 of each 21-day cycle. Combination therapy continued for up to 2 years or until disease progression, intolerable toxicity, successful surgical conversion, or other discontinuation criteria. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include ORR per mRECIST, progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety. Exploratory endpoints are surgical conversion rate and changes in AFP and PIVKA-II. A total of 30 patients will be enrolled using a Simon two-stage design (stage 1: 9 patients; stage 2: 24 patients), accounting for a 20% dropout rate.

Being tested
anlotinib combined with benmelstobart and HAIC
Keywords
anlotinib, benmelstobart, HAIC, unresectable hepatocellular carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anlotinib combined with benmelstobart and HAICDrug

    HAIC with FOLFOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² bolus followed by 2400 mg/m² over 23 h) plus oral anlotinib 10 mg (d1-14) and intravenous benmelstobart 1200 mg (d1) every 3 weeks

Study groups in NCT07806292
Study groupRoleWhat they receive
Experimental: anlotinib combined with benmelstobart and HAICExperimentalNot described
Receives: Drug: anlotinib combined with benmelstobart and HAIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR)

    ORR as assessed by the investigator using RECIST v1.1 criteria

    Measured: 12 months

Secondary outcomes (4)

  1. ORR (mRECIST)

    ORR as assessed by the investigator using mRECIST

    Measured: 12 months

  2. progression free survival (PFS)

    PFS was defined as the time from the start of treatment to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or date of death, whichever occurred first.

    Measured: up to 24 months

  3. overall survival (OS)

    OS is the time interval from the start of treatment to death due to any reason or loss of follow-up

    Measured: up to 24 months

  4. Surgical conversion rate

    The proportion of patients with initially unresectable hepatocellular carcinoma who become eligible for surgical resection after treatment, relative to all enrolled and treated patients.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start28 Apr 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Apr 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806292
Sponsor's protocol ID
SYSKY-2025-230-06
Other IDs
ChiCTR2600128357
Acronym
ABH-uHCC
Status last verified
Aug 2026
First submitted
2 Sep 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anlotinib combined with benmelstobart and HAIC in people with Unresectable Hepatocellular Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changzhen Shang, M.D, PhD (+86-20-3407 0701, shchzh2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 12 months). 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 NCT07806292.

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 8 Sep 2026.

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