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New combo therapy aims to outperform standard care for advanced liver cancer

NCT ID NCT07594340

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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