Triple therapy offers hope for hard-to-treat liver cancer
NCT ID NCT07353827
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.
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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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: * 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.
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-san University Cancer Center
Guangzhou, Guangdong, 510080, China
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Other studies related to the condition(s) this trial covers.
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