New combo therapy aims to outperform standard care for advanced liver cancer
NCT ID NCT07594340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether a chemotherapy infusion directly into the liver (HAIC) plus immunotherapy drugs works better than the standard chemo-embolization procedure (TACE) plus the same immunotherapy for people with intermediate-stage liver cancer that has spread extensively. About 300 participants will be randomly assigned to one of the two treatment groups. The study aims to find a more effective way to control the cancer and improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab and bevacizumab (immunotherapy drugs) plus either hepatic arterial infusion chemotherapy (HAIC) or transarterial chemoembolization (TACE)
- What this could lead to
- If this trial succeeds, it could show that HAIC combined with immunotherapy is more effective than the standard TACE approach for controlling liver cancer and extending survival in patients with a high tumor burden.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. The experimental treatment may not prove superior to the standard approach, and both combinations carry risks such as liver damage, bleeding, or immune-related side effects.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
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 years and older
- 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: * Diagnosis: Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients with cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC. * Age: ≥ 18 years old. * Performance Status: ECOG performance status score of 0. * Prior Treatment: No prior systemic anti-tumor therapy or transarterial interventional therapy for HCC. * Tumor Stage and Burden: Barcelona Clinic Liver Cancer (BCLC) Stage B, unsuitable for radical surgery and/or local therapy (such as ablation). * Up-To-Seven Criteria: Tumor burden exceeding the Up-To-Seven criteria, defined as the sum of the size of the largest intrahepatic tumor (in cm) and the number of tumors being greater than 7. * Tumor Distribution: Bilobar multifocal tumors. * Measurable Disease: At least one measurable lesion with arterial phase enhancement on CT/MRI. * Vascular Status: Patent portal vein with no evidence of portal vein tumor thrombus. * Extrahepatic Status: No extrahepatic metastasis. * Variceal Risk: No risk of variceal bleeding; esophagogastroduodenoscopy (EGD) within 6 months shows no gastroesophageal varices or active ulcers. * Liver Function: Child-Pugh Grade A. * Hematology: Platelets \> 75 × 10⁹/L; White Blood Cells \> 3.0 × 10⁹/L; Neutrophils \> 1.5 × 10⁹/L. * Biochemistry: Serum bilirubin ≤ 1.5 × upper limit of normal (ULN); Transaminases ≤ 3 × ULN; Serum creatinine \< 1.5 × ULN. * Physical Findings: No ascites * Albumin ≥ 30 g/L. * Coagulation: Normal coagulation function. * Expectancy: Expected survival \> 3 months. * Consent: Signed written informed consent and willingness/ability to comply with follow-up until death, study completion, or termination. Exclusion Criteria: * Histology: Known histology/cytology of fibrolamellar HCC, sarcomatoid HCC, or components of cholangiocarcinoma. * Medical History: History of hepatic encephalopathy or liver transplantation. * Effusions: Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. * Viral Hepatitis: Active Hepatitis B (HBV DNA \> 2000 IU/ml or 10⁴ copies/ml) or Hepatitis C (HCV RNA \> 10³ copies/ml); co-infection with both HBsAg and anti-HCV positive. (Eligible if levels drop below these criteria after nucleoside antiviral therapy) . * Cardiovascular (Past 12 Months): Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism. * Ongoing Cardiac Issues: Arrhythmia ≥ Grade 2 (NCI-CTCAE); QTc prolongation (Male \> 450 ms, Female \> 470 ms). * Bleeding Risk: History of gastrointestinal bleeding within 6 months or clear bleeding tendency (e.g., high-risk varices, active GI ulcer, persistent positive fecal occult blood). * Hypertension: Uncontrollable hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg despite optimal treatment); history of hypertensive crisis or hypertensive encephalopathy. * Organ Failure: Renal failure requiring hemodialysis or peritoneal dialysis; severe dysfunction of other major organs. * Second Malignancy: History of other malignancies within 3 years prior to screening (except those with negligible risk of metastasis/death such as treated cervical cancer in situ, non-melanoma skin cancer, or localized prostate cancer). * CNS Involvement: Known or new evidence of brain or leptomeningeal lesions. Coagulation Disorders: Hemophilia or bleeding tendency; currently taking therapeutic doses of coumarin derivatives (e.g., warfarin). * Pregnancy/Lactation: Pregnant or breastfeeding females; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment. * Other History: Prior organ transplant; known HIV infection; active tuberculosis; allergy to chemotherapy drugs. * Autoimmune Diseases: Active or history of autoimmune diseases (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, etc.). * General Compliance: Any serious acute/chronic physical or mental illness, or laboratory abnormalities that increase study risk or interfere with interpretation of results. * Non-compliance: History of significant non-compliance with medical protocols or inability to provide reliable informed consent.
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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 University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510000, China
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- New antibody pair takes aim at advanced liver cancer in major trial
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