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Locally Advanced Hepatocellular CarcinomaPhase 2NCT07511504

Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma

A Phase 2 study testing Angiogram, Biopsy Procedure and Biospecimen Collection in people with Locally Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Angiogram, Biopsy Procedure and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
2 Apr 2026to 1 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must provide written informed consent before any study-specific procedures or interventions are performed
  • Participants aged ≥ 18 years
  • Body weight > 30 kg
  • Patients must have radiologically, or histologically or cytologically confirmed hepatocellular cancer that is not amenable to transplant or resection:
  • Barcelona Clinic Liver Cancer Stage B or C
  • Cirrhosis grade of Child-Pugh (CP) A or CP-B7 (excluding albumin-bilirubin [ALBI] grade 3)
Show all 36Show fewer
  • Fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible
  • Disease must not be amenable to surgical resection, transplantation, or thermal ablation, or recurrent hepatocellular carcinoma (HCC) after a previous definitive therapy (surgery or thermoablative therapy)
  • Venous invasion (portal, hepatic, biliary) and infiltrative growth pattern are eligible
  • Eligible for Y-90 transarterial radioembolization (TARE) based on planning angiogram, with evidence of:
  • ≥ 30% hepatic reserve (i.e., untreated background liver) AND
  • Estimated lung exposure < 30 Gy/ treatment (or 50 Gy cumulative total)
  • Patients with bi-lobar disease amenable to simultaneous or sequential TARE are eligible
  • Eastern Cooperative Oncology Group (ECOG) 0 - 1 at enrollment
  • Recovery to baseline or ≤ grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) from toxicities related to any prior treatments, unless adverse events (AE[s]) are clinically non-significant and/or stable on supportive therapy
  • Hemoglobin ≥ 9 g/dL (≥ 90 g/L) (within 14 days before first dose of study treatment)
  • White blood cell count ≥ 2500/μL (within 14 days before first dose of study treatment)
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1500/μL), without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection (within 14 days before first dose of study treatment)
  • Platelet count ≥ 75 × 10^9/L (≥ 75,000/μL), without transfusion within 2 weeks of screening laboratory sample collection (within 14 days before first dose of study treatment)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) (within 14 days before first dose of study treatment)
  • Alkaline phosphatase (ALP) ≤ 5 x ULN (within 14 days before first dose of study treatment)
  • Total bilirubin ≤ 2 mg/dL (≤ 34.2 μmol/L) or < 2 x ULN, whichever is higher (within 14 days before first dose of study treatment)
  • Serum albumin ≥ 2.8 g/dL (within 14 days before first dose of study treatment)
  • International normalized ratio (INR) ≤ 1.7 x laboratory ULN (within 14 days before first dose of study treatment)
  • Stable renal function defined as serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCL) ≥ 40mL/min (≥ 0.675mL/sec) using the Cockcroft-Gault equation (within 14 days before first dose of study treatment)
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g (within 14 days before first dose of study treatment)
  • Has at least one measurable target lesion based on modified Response Evaluation Criteria in Solid Tumors (mRECIST)
  • Participants must have at least one lesion that is amendable to biopsy
  • Participant are asked to consent to tumor biopsies for biomarker analysis of the acquired tissue at the following timepoints: pre-treatment, on-treatment (i.e., after completing the initial combination cycle of durvalumab, tremelimumab and zanzalintinib), and at time of disease progression. These biopsies are optional and are not required for study participation
  • Sexually active fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for:
  • 96 days for sperm-producing participants or
  • 186 days for participants of child-bearing potential (POCBP) after the last dose of zanzalintinib. Additionally, sperm-producing participants must agree not to donate sperm and POCBP must agree to not donate eggs (ova, oocyte) for the purpose of reproduction during these same periods
  • POCBP must not be pregnant at screening. POCBP participants are considered to be of childbearing potential unless one of the following criteria is met:
  • Documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes.
  • Participants < 55 years-of-age must have a serum follicle stimulating (FSH) level > 40 mIU/mL to confirm menopause).
  • Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site

Who cannot join

  • Another primary tumor
  • Extrahepatic metastases
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
  • Note: Eligible participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.
  • Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed
  • Prior systemic therapy for HCC
Show all 92Show fewer
  • Prior Y-90 radioembolization
  • Note: prior transarterial chemoembolization is permitted if > 6 months prior to enrollment
  • Advanced liver disease with a CP-B7 (ALBI grade 3), CP-B8, CP-B9 or CP- C, or active gastrointestinal bleeding or encephalopathy or refractory ascites
  • Radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
  • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA4 agent, or with an agent directed to another co-inhibitory T-cell receptor (e.g., TIGIT, LAG-3, TIM-3)
  • Prior treatment with zanzalintinib, cabozantinib, or similar class of multitargeted Tyrosine Kinase Inhibitor (mTKI)
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
  • Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., rivaroxaban), or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low dose low molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
  • Note: participants must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer
  • Any complementary medications (e.g., herbal supplements or traditional medicines) to treat their HCC under study within 2 weeks before first dose of study treatment
  • Participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Unstable of deteriorating cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment.
  • Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.
  • Note: Participants with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
  • Note: Participants who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.
  • Prior history of myocarditis
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
  • Participant has evidence of tumor invading the GI tract,
  • Active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis
  • Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.
  • Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
  • Known gastric or esophageal varices that are untreated or incompletely treated with bleeding or high risk for bleeding. Participants treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to study entry are eligible.
  • Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before start of study intervention
  • Lesions invading a major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Participants with lesions invading the hepatic portal vasculature are eligible
  • Elevated lung shunting precluding safe treatment with Y-90 within acceptable thresholds of lung exposure, defined as > 30 Gy/treatment or 50 Gy total for multiple treatments
  • Patients with future liver remnant volume < 30% after Y-90 treatment
  • Patients in whom Y-90 is deemed unsafe due to risks of extra-pulmonary non-target embolization
  • Any deposition to the GI tract (per 99mTc-MAA SPECT-CT or Cone Beam CT)
  • Hepatic artery catheterization is contraindicated (e.g., vascular abnormalities or bleeding diathesis)
  • Severe liver dysfunction, including hepatic encephalopathy, clinically evident ascites or treatment with diuretics for ascites
  • Type Vp4 Portal vein tumor thrombosis (PVTT) involvement and lack of Tc-99m MAA deposition on the PVT per Tc-99m MAA SPECT/CT
  • Participants with renal failure currently requiring dialysis of any kind are not eligible
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation
  • Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients
  • Other clinically significant disorders that would preclude safe study participation.
  • Active infection requiring systemic treatment.
  • Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for participants meeting all of the following criteria:
  • On stable anti-retroviral therapy;
  • CD4+ T cell count ≥ 200/µL; and
  • An undetectable viral load.
  • Note: HIV testing is to be performed at screening if and as required by local regulation.
  • Note: To be eligible, participants taking CYP inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.
  • Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider
  • Uncontrolled hepatitis B Virus (HBV) infection. Participants with controlled hepatitis B virus (HBV), defined as receiving effective antiviral therapy and adequate viral suppression (i.e., HBV deoxyribonucleic acid [DNA] ≤ 2000 IU/mL) are eligible.
  • Note: participants must meet liver function inclusion parameters (i.e., ALT, AST, bilirubin)
  • Hepatitis C (HCV) infection. Participants with active, controlled HCV infection are eligible provided liver function meets eligibility criteria and are receiving management of the disease per local institutional practice.
  • Serious non-healing wound/ulcer/bone fracture.
  • Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.
  • Malabsorption syndrome
  • Pharmacologically uncompensated, symptomatic hypothyroidism.
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ or allogenic stem cell transplant
  • Major surgery (e.g., GI surgery) within 8 weeks before first dose of study treatment. Minor surgeries (e.g., simple excision) within 5 days before first dose of study treatment. Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Participant with clinically relevant ongoing complications from prior surgery are not eligible
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 470 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Participants with a history of additional risk factors for torsades de pointes (e.g., long QT syndrome) are also excluded [add reference for Fridericia formula].
  • Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility
  • Any active, known or suspected autoimmune disease will be excluded, with the following exceptions:
  • Type 1 diabetes mellitus.
  • Hypothyroidism only requiring hormone replacement.
  • Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
  • Conditions not expected to recur in the absence of an external trigger
  • Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Free thyroxine outside the laboratory normal reference range. Asymptomatic participants with free thyroxine abnormalities are eligible per investigator's discretion
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment. Note the following exceptions:
  • Inhaled, intranasal, intra-articular, or topical steroids are permitted.
  • Adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is permitted
  • Prior allogeneic stem cell or solid organ transplantation
  • Receipt of a live, attenuated vaccine within 30 days prior to enrollment
  • Documented hepatic encephalopathy within 6 months before first dose of study treatment
  • Clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in diuretics) within 6 months before first dose of study treatment
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, safety of participation, or interpretation of results. This includes significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome) or any other serious medical condition or abnormality in clinical laboratory tests that meet these criteria in the investigator's opinion
  • Patient is pregnant or lactating
  • Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube, or unwillingness or inability to receive IV administration
  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6
  • History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
  • Participants with any condition that, in the opinion of the investigator, could jeopardize the participant's safety or adherence to the study protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Adel Kardosh, 503-494-8534, kardosh@ohsu.edu

    Adel Kardosh

Other trials in United States

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety of Y-90, Durvalumab, Tremelimumab, and Zanzalintinib in Patients With Unresectable and Locally-Advanced Hepatocellular Carcinoma

This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess proportion of participants that are progression-free at 6 months.

SECONDARY OBJECTIVES:

  1. To assess safety of study intervention. II. To estimate objective response rate (ORR) for study intervention. III. To estimate disease control rate (DCR) for study intervention. IV. To estimate time to disease progression (TTP) for study intervention. V. To estimate progression-free survival. VI. To estimate overall survival (OS) for study intervention.

EXPLORATORY OBJECTIVE:

  1. To evaluate therapy induced changes in the tumor and tumor immune microenvironments.

OUTLINE:

CYCLE 1: Patients receive tremelimumab intravenously (IV) and durvalumab IV, over 60 minutes, on day 1. 7-14 days later patients undergo transarterial radioembolization with yttrium (Y)-90 in the absence of disease progression or unacceptable toxicity. 7 days to 12 weeks later patients proceed to cycle 2.

CYCLE 2-12: Patients receive durvalumab IV, over 30-60 minutes, on day 1 and zanzalintinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo angiogram during screening and undergo single photon emission computed tomography (SPECT), computed tomography (CT) scan or magnetic resonance imaging (MRI), and blood and urine sample collection throughout the study. Patients optionally undergo tumor biopsy throughout the study.

After completion of study treatment, patients are followed up at 100 days and every 6 months for 1 year.

Being tested
Angiogram, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Durvalumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • AngiogramProcedure or surgery

    Undergo angiogram

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • DurvalumabBiological

    Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT

  • TremelimumabBiological

    Also called Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP 675, CP 675206, CP-675

    Given IV

  • Yttrium-90 Microsphere RadioembolizationProcedure or surgery

    Also called Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

    Given via transartieral radioembolization procedure

  • ZanzalintinibDrug

    Also called Multi-kinase Inhibitor XL092, XL 092, XL-092, XL092

    Given PO

Study groups in NCT07511504
Study groupRoleWhat they receive
Treatment (Y-90, tremelimumab, durvalumab, zanzalintinib)ExperimentalCYCLE 1: Patients receive tremelimumab IV and durvalumab IV, over 60 minutes, on day 1. 7-14 days later patients undergo transarterial radioembolization with Y-90 in the absence of disease progression or unacceptable toxicity. 7 days to 12 weeks later patients proceed to cycle 2. CYCLE 2-12: Patients receive durvalumab IV, over 30-60 minutes, on day 1 and zanzalintinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo angiogram during screening and undergo SPECT, CT scan or MRI, and blood and urine sample collection throughout the study. Patients optionally undergo tumor biopsy throughout the study.
Receives: Procedure: Angiogram; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Procedure: Magnetic Resonance Imaging; Procedure: Single Photon Emission Computed Tomography; Biological: Tremelimumab; Procedure: Yttrium-90 Microsphere Radioembolization; Drug: Zanzalintinib

What is being measured

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

  1. Proportion of progression-free at 6-months

    Will be reported with 95% exact confidence interval.

    Measured: From first dose of study intervention, up to 6 months

Secondary outcomes (6)

  1. Incidence of grade ≥ 3 adverse events (AEs)

    Assessed per Common Terminology Criteria for Adverse Events version 5.0. The 95% confidence interval will be reported with the point estimate of toxicity rate.

    Measured: From first dose of study intervention to 30 days for AEs or 100 days for serious adverse events (SAEs) from last dose of study intervention

  2. Objective response rate

    Defined as the proportion of participants that achieve a best overall response of complete response (CR) or partial response (PR) per modified Response Evaluation Criteria in Solid Tumors (mRECIST). Will be reported with 95% exact confidence interval.

    Measured: From first dose of study intervention to last dose of study intervention

  3. Disease control rate

    Defined as the proportion of participants that achieve a best overall response of CR, PR, or stable disease (≥ 6 months, per mRECIST) without evidence of radiologic progression prior to this point. Will be reported with 95% exact confidence interval.

    Measured: From first dose of study intervention to date of progression up to 12 months from last dose of study intervention

  4. Time to progression (TTP)

    Assessed per mRECIST. Will be characterized using the Kaplan-Meier method. Kaplan-Meier curves of TTP will be presented. Median TTP, quartiles and progression rate after specific time points (for example, after 6 and 12 months on treatment) will be estimated from the survival curves. All these parameter estimates will be reported together with their 95% confidence intervals.

    Measured: From first dose of study intervention to date of progression up to 12 months from last dose of study intervention

  5. Progression free survival

    Will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals.

    Measured: From first dose of study intervention to date of progression or death (any cause) up to 12 months from last dose of study intervention

  6. Overall survival

    Will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals.

    Measured: From first dose of study intervention to date of death (any cause) up to 12 months from last dose of study intervention

Timeline

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

  1. First posted6 Apr 2026
  2. Study start2 Apr 2026 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511504
Sponsor's protocol ID
STUDY00027844
Other IDs
NCI-2026-01857, STUDY00027844
Status last verified
Mar 2026
First submitted
30 Mar 2026
Last updated
6 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Angiogram, Biopsy Procedure and Biospecimen Collection in people with Locally Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.

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 36 inclusion and 92 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: opening soon, as of the sponsor's last update on 6 Apr 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of progression-free at 6-months (time frame: From first dose of study intervention, up to 6 months). 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 NCT07511504.

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 6 Apr 2026.

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