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Triple therapy offers hope for hard-to-treat liver cancer

NCT ID NCT07353827

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new combination of treatments for people with a specific liver cancer (intrahepatic cholangiocarcinoma) that cannot be surgically removed. The treatment includes chemotherapy delivered directly to the liver, along with two oral and intravenous drugs. The goal is to see if this combination can shrink tumors and improve survival. About 36 participants will be enrolled.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 to 75 years

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: * Male or female participants aged 18 to 75 years. * Histologically or clinically diagnosed Hepatocellular Carcinoma (HCC) according to AASLD or EASL guidelines. * Disease stage classified as Barcelona Clinic Liver Cancer (BCLC) stage B (unresectable) or stage C. * No prior systemic treatment for advanced HCC (treatment-naïve). * At least one measurable lesion according to RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Child-Pugh liver function class A (score 5-6). * Life expectancy of at least 3 months. * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, Platelets ≥ 75 × 10\^9/L, and Hemoglobin ≥ 90 g/L. * Adequate liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 5 × ULN. * Adequate renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. * Adequate coagulation function: INR ≤ 1.5 or PT ≤ 1.5 × ULN. * Participants suitable for hepatic artery catheterization and HAIC treatment as assessed by the investigator. * Willingness to provide written informed consent. Exclusion Criteria: * Known hypersensitivity or allergy to Oxaliplatin, Fluorouracil, Leucovorin, Donafenib, Pucotenlimab, or any of their excipients. * Previous treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other immunomodulatory agents. * Diagnosis of other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). * Presence of central nervous system (CNS) metastases. * Active, known, or suspected autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic treatment. * History of gastrointestinal bleeding, esophageal or gastric varices with bleeding risk, or other active bleeding within 6 months prior to enrollment. * Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, or uncontrolled hypertension. * Active infection requiring systemic antibiotic therapy. * Hepatitis B virus (HBV) DNA \> 2000 IU/mL (participants must receive antiviral treatment to suppress viral load). * Known Human Immunodeficiency Virus (HIV) infection or active Syphilis infection. * Anatomy unsuitable for hepatic arterial catheterization (e.g., severe vascular variation or occlusion). * Pregnant or breastfeeding women. * Any condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the integrity of the study data.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension intrahepatic cholangiocarcinoma

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-san University Cancer Center

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.