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RecruitingPhase 2NCT06999694

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

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

45 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

HCC - Hepatocellular CarcinomaDurvalumabTremelimumabProton Radiotherapy

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%. 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining proton radiation therapy with two immunotherapy drugs (tremelimumab and durvalumab) can improve outcomes for people with liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed or transplanted. **You may be eligible if...** - You are 18 or older and have been diagnosed with liver cancer that cannot be surgically removed - Your liver cancer is at an intermediate or advanced stage (BCLC stage B or C) - Your liver function is relatively preserved (Child-Pugh score 5–6) - Your blood counts, liver, and kidney function meet the study requirements - You have been tested for hepatitis B and C **You may NOT be eligible if...** - You have had another cancer in the past - Your liver function is significantly impaired - You have active autoimmune disease or are on immunosuppressants - You are pregnant or breastfeeding - You have had prior liver-directed therapies that would exclude you (per study criteria) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton radiotherapy

* 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.

DRUGTremelimumab

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

DRUGDurvalumab

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.

Locations(1)

Chang Gung Memorial Hospital at Linkou

Taoyuan City, Taiwan, Taiwan

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NCT06999694

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