Actively Recruiting
Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Led by Chang Gung Memorial Hospital · Updated on 2025-09-10
45
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma (HCC) unsuitable for surgery or transplant, with tumors less than 20 cm total and no single lesion larger than 15 cm confirmed by biopsy or imaging
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate) or C (advanced)
- Child-Pugh score between 5 and 6 within 28 days before registration
- Documented hepatitis B virus (HBV) status by serology
- Documented hepatitis C virus (HCV) status by serology
- Ability and willingness to provide written informed consent
- Adequate bone marrow, liver, and kidney function within 4 weeks before registration as indicated by hemoglobin ≥ 9.0 g/dL, neutrophil count ≥ 1,000/mm3, platelet count ≥ 50,000/μL, total bilirubin less than 2.5 mg/dL, serum albumin above 2.8 g/dL, ALT and AST ≤ 3 times upper limit of normal, prothrombin time ≤ 6 seconds prolonged, and serum creatinine ≤ 1.5 mg/dL
You will not qualify if you...
- Prior invasive cancer unless disease-free for at least 2 years
- Previous radiation therapy to the liver area overlapping proposed treatment fields
- Previous selective internal radiotherapy or hepatic arterial yttrium therapy
- Untreated active hepatitis B or hepatitis C infection
- Moderate to severe or hard-to-treat ascites
- Distant metastases not fully treatable by proton radiotherapy
- Untreated or incompletely treated esophageal or gastric varices
- Severe active health conditions including recent unstable angina, heart failure, heart attack, serious infections, recent bleeding, clotting disorders, or uncontrolled psychiatric illness
- Pregnancy or unwillingness/inability to use effective contraception for women of childbearing potential and sexually active men
- Prior solid organ transplant
- Current or past autoimmune diseases such as autoimmune hepatitis, inflammatory bowel disease, lupus, rheumatoid arthritis, and others
- History or presence of bleeding or clotting disorders, significant cardiac disease, or gastrointestinal perforation
- Inability to treat all tumor sites with proton radiotherapy
- Known HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital at Linkou
Taoyuan City, Taiwan, Taiwan, 333
Actively Recruiting
Research Team
R
Rodney Cheng-En Hsieh, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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