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Hepatocellular CarcinomaPhase 2NCT04945720

Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma

A Phase 2 study testing Hepatic artery infusion chemotherapy（HAIC） and Durvalumab in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hepatic artery infusion chemotherapy (HAIC) and anti-programmed cell death protein-1ligand (PD-L1) immunotherapy have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC), respectively. However, the combination of the two treatments has not been reported. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Hepatic artery infusion chemotherapy（HAIC） and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
11 Apr 2022to 5 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated, written informed consent form (ICF) and any locally required authorization obtained from the patient prior to any mandatory study specific procedures, sampling, and analyses.
  • Provision of signed and dated written genetic informed consent prior to optional collection of sample for genetic analysis.
  • Age ≥18 years and < 75 years at the time of screening.
  • Portal vein invasion（Vp3 and/orVp4） or extrahepatic oligosaccharides were detected by baseline imaging. Oligosaccharides were defined as no more than two extrahepatic organs and no more than three tumors.
  • Child-Pugh score class A to B7
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
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  • Patients with HBV infection, which is characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice. HBV antiviral therapy must be initiated prior to randomization and patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication. Patients must show evidence HBV stabilization or signs of viral response (e.g., reduction HBV DNA levels) prior to starting IP. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (<10 IU/ml or under the limit of detection per local lab standard) do not require anti-viral therapy prior to randomization. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU/ml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
  • Patients with HCV infection must have management of this disease per local institutional practice throughout the study. HCV diagnosis is characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrollment.
  • At least 1 measurable intrahepatic lesion suitable for repeat assessments according to the following mRECIST criteria: （1）Liver lesions that show typical features of HCC on IV contrast-enhanced CT or MRI scans, ie, hypervascularity in the arterial phase with washout in the portal or the late venous phase；（2）Viable, non-necrotic portion (arterial phase IV contrast-enhancing) that can be accurately measured at baseline as ≥10 mm in the longest diameter.
  • Adequate organ and marrow function as defined below. Criteria "a," "b," "c," and "f" may not be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.
  • Hemoglobin ≥9.0 g/dL、Absolute neutrophil count ≥1000/µL、Platelet count ≥75000/µL、Total bilirubin ≤2.0 × the upper limit of normal (ULN)、alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN、Albumin ≥2.8 g/dL、International normalized ratio ≤1.6、2+ proteinuria or less urine dipstick reading、Calculated creatinine clearance (CL) ≥30 mL/min as determined by Cockcroft-Gault (using actual body weight) or 24hour urine creatinine CL
  • Males:
  • Creatinine CL = Weight (kg) × (140 - Age) (mL/min) 72 × serum creatinine (mg/dL)
  • Females:
  • Creatinine CL = Weight (kg) × (140 - Age) × 0.85 (mL/min) 72 × serum creatinine (mg/dL)
  • Must have a life expectancy of at least 12 weeks.
  • Body weight >30 kg

Who cannot join

  • A history of liver decompensation, such as refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy; Uncontrolled complications, including but not limited to: Persistent or activity (except the HBV and HCV) infection, symptoms of congestive heart failure and uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active ILD, severe chronic GI disease accompanied by diarrhea, or compliance with requirements may limit the research, resulted in significant increase risk of AE or influence Subjects provided psychiatric/social problem status on their ability to provide written informed consent.A history of active primary immunodeficiency or human immunodeficiency virus; Active or previous records of autoimmune disease or inflammatory diseases, including inflammatory bowel disease (e.g., colitis or crohn's disease], diverticulitis, except [diverticulosis], systemic lupus erythematosus (sle), sarcoidosis syndrome or wegener syndrome (e.g., granulomatous vasculitis, gray's disease, rheumatoid arthritis, the pituitary gland inflammation and uveitis]).
  • Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof;
  • Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.
  • Tumors of the central nervous system, including metastatic brain tumors;
  • Pregnant women or breast-feeding patients;
  • Complicated with other malignant tumors:
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  • Malignant tumors that have been treated for therapeutic purposes, have no known active disease for ≥5 years prior to the first administration of the study drug, and have a low potential risk of recurrence
  • Fully treated non-melanoma skin cancer or malignant freckle moles with no evidence of disease
  • Fully treated carcinoma in situ without evidence of disease
  • Prior to the initial dosing of the study drug, they had received anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy
  • HAIC treatment was received prior to initial dosing of the study drug
  • Has received anti-tumor system therapy for HCC. Non-anti-tumor purpose combined hormone therapy (e.g., hormone replacement therapy) is excluded.
  • Is currently using, or has used an immunosuppressive drug within 14 days prior to the first dose of the investigational drug. This standard has the following exceptions:
  • intranasal, inhaled, topical or topical steroids (e.g., intraarticular)
  • Systemic corticosteroid therapy not exceeding 10 mg/ day of prednisone or its physiological equivalent as a prophylactic use of steroids for hypersensitivity (e.g., CT scan pretherapy medication)
  • Steroids as a prophylactic for allergic reactions.
  • A live attenuated vaccine was administered within 30 days prior to the first administration of the study drug. Note: If enrolled, patients shall not receive live attenuated vaccine within 30 days of receiving study drug therapy and after the last administration of study drug.
  • Pregnant or lactating women, or fertile men or women who do not want to use high-efficiency contraceptives, 6 months after the last dosing of study treatment, from screening to study treatment. Based on the patient's preferred and customary lifestyle, abstinence during treatment and washout is an acceptable contraceptive method.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 500060

Other trials in China

About this study

Official title: An Open Label Pilot Study to Evaluate Efficacy and Safety of Durvalumab(MEDI 4736) With Hepatic Artery Infusion Chemotherapy (HAIC) in the Chinese Advanced HCC Patients With Severe Portal Vein Tumor Thrombosis (PVTT)(Vp3 or Vp4) DurHope

Hepatic artery infusion chemotherapy (HAIC) and anti-programmed cell death protein-1ligand (PD-L1) immunotherapy have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC), respectively. However, the combination of the two treatments has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy and safety in patients with advanced hepatocellular carcinoma (Ad-HCC) with portal vein embolism who are undergoing hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment combined with anti-PD-L1 immunotherapy (Durvalumab) by designing an open, single-arm phase II clinical study.

Read the detailed description

Femoral artery puncture and catheterization were performed in every cycle of treatment,a micro-catheter was inserted and located in feeding hepatic artery. The therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose : Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity.Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.

Being tested
Hepatic artery infusion chemotherapy（HAIC）, Durvalumab
Keywords
Durvalumab, PD-L1, Arterial infusion chemotherapy, FOLFOX, Oxaliplatin, Fluorouracil
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatic artery infusion chemotherapy（HAIC）Procedure or surgery

    hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

  • DurvalumabDrug

    Also called Durvalumab Injection

    Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).

Study groups in NCT04945720
Study groupRoleWhat they receive
Hepatic artery infusion chemotherapy（HAIC） plus DurvalumabExperimentalThe therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).
Receives: Procedure: Hepatic artery infusion chemotherapy（HAIC）; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. One-Year Overall Survival Rate

    Percentage of patients who survived one year after inclusion

    Measured: one year

Secondary outcomes (2)

  1. Progression Free Survival

    Progression free survival is defined as the interval from treatment initiation to either disease progression or death from any cause)

    Measured: 1 year

  2. Objective Response Rate

    The percentage of patients who achieved a complete or partial response at some point in their life

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start11 Apr 2022
  3. Primary completion5 Jul 2024
  4. Study completion5 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945720
Sponsor's protocol ID
B2021-111-01
Status last verified
Feb 2026
First submitted
16 Jun 2021
Last updated
25 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.

    PubMed 29471013

  • Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.

    PubMed 28592441

  • Yi J, Wang J, Zhang Y, Jiang X, Chen S, Xu J, Wu X, Zhong S, Chen Q, Hu Y, Song Y, Tan G, Zhang Y, Li J, Zhao M, Lyu N. Durvalumab plus HAIC-FOLFOX followed by maintenance durvalumab for hepatocellular carcinoma with major portal invasion: phase 2 DurHope study. Nat Commun. 2026 May 18;17(1):7837. doi: 10.1038/s41467-026-73131-y.

    PubMed 42151180

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatic artery infusion chemotherapy（HAIC） and Durvalumab in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One-Year Overall Survival Rate (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945720, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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