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

ConditionsHCC - Hepatocellular CarcinomaDurvalumabTremelimumabProton Radiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Proton radiotherapy

    Radiation

    * 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.

  • Tremelimumab

    Drug

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

  • Durvalumab

    Drug

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Proton radiotherapy combined with Tremelimumab and DurvalumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Time frame
12 months

Secondary outcomes

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

Time frame
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

Time frame
12 months
3

Overall Response Rate

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

Time frame
12 months
4

Overall survival

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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