Can a Three-Pronged attack shrink untreatable liver tumors?
NCT ID NCT07806292
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase II trial tests whether combining anlotinib, benmelstobart, and hepatic arterial infusion chemotherapy (HAIC) can shrink tumors in people with unresectable hepatocellular carcinoma, the most common type of liver cancer. The study enrolls adults aged 18 to 75 with confirmed unresectable HCC who have not received prior systemic therapy. Participants receive the three treatments together every three weeks, and researchers measure the objective response rate to see if the tumors shrink significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anlotinib combined with benmelstobart and HAIC (hepatic arterial infusion chemotherapy)
- What this could lead to
- If effective, this combination could offer a new first-line treatment option for people with liver cancer that cannot be surgically removed, potentially shrinking tumors and delaying progression.
- What could go wrong
- This is a small, early-phase study (30 participants) without a control group, so results may not be conclusive. The combination may cause significant side effects, and the response rate could be lower than hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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: a) 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITINGGuangzhou, Guangdong, China
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