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HCC - Hepatocellular CarcinomaPhase 2Proton-STRIDENCT06999694

Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC

A Phase 2 study testing Proton radiotherapy, Tremelimumab and Durvalumab in people with HCC - Hepatocellular Carcinoma and Durvalumab, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Tremelimumab plus durvalumab (STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC), yet it shows limited efficacy with an ORR of only 20.1%. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Proton radiotherapy, Tremelimumab and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTaiwan
Study dates
22 May 2025to 31 May 2033
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

  • Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of < 20 cm, and no one lesion > 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:
  • Histologically or cytologically proven diagnosis of HCC.
  • Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
  • Age ≥18 years at the time of signing informed consent document.
  • ECOG performance status 0-1.
  • Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).
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  • Child-Pugh score 5-6 liver function within 28 days of study registration.
  • Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.
  • Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.
  • Ability to understand and the willingness to sign a written informed consent document
  • Adequate bone marrow, liver, and renal function within 4 weeks before study registration
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3
  • Platelet count ≥ 50,000/μL
  • Total bilirubin < 2.5 mg/dL
  • Serum albumin >2.8 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)
  • Prothrombin time ≤ 6 seconds prolonged
  • Serum creatinine ≤ 1.5 mg/dL

Who cannot join

  • Prior invasive malignancy unless disease free for a minimum of 2 years
  • Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
  • Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
  • Untreated active hepatitis B or hepatitis C
  • Moderate to severe or intractable ascites
  • Presence of distant metastases that cannot be encompassed by proton radiotherapy
Show all 21Show fewer
  • Untreated or incomplete treated esophageal or gastric varices
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  • Myocardial infarction within the last 6 months prior to study entry
  • Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry
  • A bleeding episode within 6 months prior to study entry due to any cause.
  • Thrombolytic therapy within 28 days prior to study entry.
  • Known bleeding or clotting disorder.
  • Uncontrolled psychotic disorder
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior solid organ transplantation.
  • Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.
  • Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
  • Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints cannot be met for covering all sites of liver tumors using proton radiotherapy.)
  • Known HIV infection.

Trial locations and contacts

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

Rodney Cheng-En Hsieh, MD, PhD contact

+88633281200 ext. 7000

rodney445@gmail.com

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan City, Taiwan, 333

    Rodney Cheng-En Hsieh, MD, PhD, +886-3-328-1200 ext. 7000, rodney445@gmail.com

    Rodney Cheng En Hsieh, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: Proton Radiotherapy Combined With Tremelimumab and Durvalumab for BCLC Stage B and C Hepatocellular Carcinoma

Tremelimumab plus durvalumab (STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC), yet it shows limited efficacy with an ORR of only 20.1%. Proton radiotherapy (RT), known for its precision and tissue-sparing advantages, has demonstrated improved survival outcomes and reduced toxicity compared to X-ray RT. Retrospective data suggest that combining proton RT with immune checkpoint inhibitors yields a promising ORR of 61.5%. Preclinical studies further support enhanced antitumor immunity when RT is combined with PD-L1 and CTLA-4 blockade. This phase II, single-arm clinical trial aims to evaluate the safety, efficacy, and immunologic effects of combining proton RT with tremelimumab and durvalumab in patients with unresectable HCC.

Being tested
Proton radiotherapy, Tremelimumab, 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.

  • Proton radiotherapyRadiation

    • 72.6 CGE in 22 fractions for tumors ≤1 cm from the hepatic hilum, bowel, and heart.
    • 66 CGE in 10 fractions for tumors >1 cm from the hepatic hilum, bowel, and heart.

  • TremelimumabDrug

    Also called Imjudo

    Tremelimumab 300 mg will be administered as an IV infusion for one dose

  • DurvalumabDrug

    Durvalumab 1500 mg will be administered as an IV infusion every 4 weeks.

    Treatment Duration Guidelines:

    • Complete Response (CR): Patients who achieve a CR within one year of treatment will continue durvalumab for a total duration of two years.
    • Partial Response (PR): Patients who achieve a PR should continue durvalumab until achieving CR, disease progression (PD), or for a total duration of two years.
    • Stable Disease (SD): Patients with SD will receive duvalumab for a total of 6 doses.
Study groups in NCT06999694
Study groupRoleWhat they receive
Proton radiotherapy combined with Tremelimumab and DurvalumabExperimentalPatients undergo proton radiotherapy combined with Tremelimumab and Durvalumab.
Receives: Radiation: Proton radiotherapy; Drug: Tremelimumab; Drug: Durvalumab

What is being measured

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

  1. Progression free survival

    Progression free survival is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1

    Measured: 12 months

Secondary outcomes (5)

  1. Local control

    Local control is defined as the time from signing the informed consent to the first occurrence of disease progression in the irradiated field according to RECIST1.1

    Measured: 12 months

  2. Time to progression

    Time to progression is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1

    Measured: 12 months

  3. Overall Response Rate

    Overall Response Rate is defined as a complete or partial response according to RECIST1.1

    Measured: 12 months

  4. Overall survival

    Overall survival is defined as the time from signing the informed consent to death from any cause.

    Measured: 12 months

  5. Incidence and severity of adverse events

    Adverse events will be graded using CTCAE v5

    Measured: 12 months

Timeline

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

  1. First posted31 May 2025
  2. Study start22 May 2025
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 May 2033 (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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999694
Sponsor's protocol ID
202500583A3
Acronym
Proton-STRIDE
Status last verified
Sep 2026
First submitted
22 May 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing individual participant data (IPD) with other researchers requires IRB review and approval. Presently, we do not have a plan to provide IPD to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proton radiotherapy, Tremelimumab and Durvalumab in people with HCC - Hepatocellular Carcinoma and Durvalumab, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 19 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 1 Oct 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 Taiwan. 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?

Contact Rodney Cheng-En Hsieh, MD, PhD (+88633281200 ext. 7000, rodney445@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 12 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 NCT06999694.

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 1 Oct 2026.

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