Actively Recruiting
Photon Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Led by Chang Gung Memorial Hospital · Updated on 2025-06-05
45
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tremelimumab plus durvalumab (the STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC); however, it demonstrates limited efficacy, with an objective response rate (ORR) of only 20.1%. Radiation therapy (RT) is highly effective in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Preclinical studies have shown that combining RT with PD-L1/PD-1 blockade promotes immunogenic cell death and enhances antigen presentation by dendritic cells, thereby boosting systemic T cell-mediated antitumor responses in mouse models. The addition of CTLA-4 inhibition further enhances antigen cross-priming following RT. Recent retrospective data also indicate that combining RT with immune-oncology agents is associated with improved overall survival and prolonged time to progression compared to RT or immunotherapy alone. However, the clinical benefit and immunologic impact of combining RT with tremelimumab and durvalumab have not yet been evaluated in prospective clinical trials for unresectable HCC. This phase II, single-arm clinical trial aims to assess the safety, efficacy, and immunologic effects of combining proton RT with tremelimumab and durvalumab in patients with unresectable HCC.
CONDITIONS
Official Title
Photon 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 unsuitable for surgery or transplant
- Multiple lesions allowed with total tumor size less than 20 cm and no single lesion larger than 15 cm
- Diagnosis confirmed by biopsy or typical imaging features
- Age 18 years or older
- ECOG performance status 0 or 1
- Barcelona Clinic Liver Cancer (BCLC) stage B or C
- Child-Pugh liver function score of 5 or 6 within 28 days before enrollment
- Documented hepatitis B virus status by serology
- Documented hepatitis C virus status by serology
- Ability and willingness to sign informed consent
- Adequate bone marrow, liver, and kidney function within 4 weeks before enrollment including hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,000/mm3, platelets ≥ 50,000/µL, total bilirubin < 2.5 mg/dL, albumin > 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 liver area radiotherapy overlapping planned treatment fields
- Prior selective internal radiotherapy or hepatic arterial yttrium therapy
- Active untreated hepatitis B or C infection
- Moderate to severe or uncontrollable ascites
- Distant metastases not treatable by photon radiotherapy
- Untreated or incompletely treated esophageal or gastric varices
- Severe active medical conditions including unstable angina, recent heart attack, recent serious infections, recent bleeding episodes, bleeding or clotting disorders, or uncontrolled psychosis
- Pregnancy or childbearing potential without adequate contraception
- Prior solid organ transplant
- Prior or active autoimmune diseases including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, lupus, rheumatoid arthritis, and others
- Inability to treat all disease sites with photon radiotherapy
- Known HIV infection
AI-Screening
AI-Powered Screening
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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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