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AzTrials

Hepatocellular Carcinoma (HCC)Phase 2PRISMNCT06994299

A Pilot Trial of Preoperative Irradiation With the STRIDE (Single Dose of Tremelimumab With Ongoing Durvalumab) Regimen (PRISM) for Resectable/Advanced Hepatocellular Carcinoma

A Phase 2 study testing Radiation Therapy, Tremelimumab and Durvalumab in people with Hepatocellular Carcinoma (HCC), run by Weill Medical College of Cornell University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an early-phase study testing a new combination treatment for cancer. participants will receive a type of radiation therapy called MRI-guided or CT-guided radiotherapy, depending on which imaging method is safe for them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Radiation Therapy, Tremelimumab and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Oct 2025to 1 Jul 2028
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Age ≥ 18 years
  • ECOG performance status 0-1
  • Life expectancy for at least 12 weeks
  • Body weight >30kg
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  • LIRADS 5 or biopsy confirmed hepatocellular carcinoma (HCC)
  • Patients with histologically confirmed HCC (Documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by AASLD criteria in cirrhotic subjects is required (presence of arterial hypervascularity with venous washout).
  • For subjects without cirrhosis, histological confirmation is mandatory.
  • Patient's must have resectable HCC. The determination of resectability status will ultimately lie in the clinical judgment of the surgical oncologist, medical oncologist, and radiation oncologist involved in the care of the patient.
  • Patient must have measurable disease defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional techniques or
  • o ≥ 10 mm with more sensitive techniques such as MRI or spiral CT (Computed Tomography) scan.
  • Patient can have prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (ablation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy (but not anti-PD-1 or anti-CTLA-4 therapy).
  • Patients with grade 2+ neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
  • No evidence of distant metastases
  • No infections requiring systemic antibiotic treatment
  • Hgb >9.0 gm/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5x upper limit of normal

Who cannot join

  • Any other malignancy from which the patient has been disease-free for less than 5 years, except for non- melanoma skin cancer, or in situ carcinoma of any site.
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
  • Patients who have organ allografts.
  • Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the study (other than defined by protocol); fine needle aspirations or core biopsies within 7 days prior to first dose of study drug. NOTE: Patients will be allowed to start cycle 1 day 1 therapy after 24 hours from pre-treatment biopsy.
  • Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]).
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  • Known history of testing positive for human immunodeficiency virus (HIV) (positive HIV 1 /2 antibodies) or known acquired immunodeficiency syndrome (AIDS).
  • Active tuberculosis infection (clinical evaluation that may include history, physical examination, and radiographic findings or tuberculosis testing in line with local practive).
  • Any underlying medical condition, which, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
  • Patients who have had a history of acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra- abdominal abscess, GI obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study.Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of stroke within the past year.
  • History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of >140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
  • Patients who have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York-Presbyterian Weill Cornell Medical College

    New York, New York, 11355

Other trials in United States

About this study

This is an early-phase study testing a new combination treatment for cancer. participants will receive a type of radiation therapy called MRI-guided or CT-guided radiotherapy, depending on which imaging method is safe for them. The radiation will be given in three sessions, each delivering a moderate dose (8 Gray), focused only on the visible tumor.

At the same time, participants will receive immunotherapy, which is a treatment that helps the immune system fight cancer. This includes one dose of a drug called Tremelimumab and regular doses of another drug called Durvalumab, given every four weeks.

The goal of this study is to see if this combination is safe and shows signs of helping patients.

Being tested
Radiation Therapy, Tremelimumab, Durvalumab, Surgery
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Radiation TherapyRadiation

    Hypofractionated radiotherapy - 8Gy x3 fractions (week 0)

  • TremelimumabDrug

    Tremelimumab - single dose of 300 mg IV (week 0).

  • DurvalumabDrug

    Durvalumab-500 mg IV every 4-weeks (weeks 0-3) prior to hepatic resection

  • SurgeryProcedure or surgery

    Hepatic resection

Study groups in NCT06994299
Study groupRoleWhat they receive
Stereotactic Body Radiotherapy for HCCExperimentalHypofractionated radiotherapy - 8Gy x3 fractions (week 0) Tremelimumab - single dose of 300 mg IV (week 0). Durvalumab - 1500 mg IV every 4-weeks (weeks 0-3) prior to hepatic resection Surgery - hepatic resection (week 7)
Receives: Radiation: Radiation Therapy; Drug: Tremelimumab; Drug: Durvalumab; Procedure: Surgery

What is being measured

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

  1. Safety, as measured by the number of Grade 3+ CTCAE treatment related toxicity rates within three months from start of treatment

    Measured: Within 3 months from start of treatment

  2. Efficacy, as measured by major pathologic response rates determined from resected surgical specimens

    Measured: Week 7

Secondary outcomes (1)

  1. Feasibility as measured by the recruitment timeline

    The desired requirement timeline is to enroll 10 participants in 6 months

    Measured: 24 months

Timeline

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

  1. First posted29 May 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Why it stopped: Drug and financial support not available for the study.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06994299
Sponsor's protocol ID
24-03027257
Acronym
PRISM
Status last verified
Nov 2025
First submitted
20 May 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy, Tremelimumab and Durvalumab in people with Hepatocellular Carcinoma (HCC), run by Weill Medical College of Cornell University 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 18 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Nov 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Safety, as measured by the number of Grade 3+ CTCAE treatment related toxicity rates within three months from start of treatment (time frame: Within 3 months from start of treatment). The study lists 2 primary outcomes in all. 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 NCT06994299.

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 18 Nov 2025.

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