Actively Recruiting
Proton Radiotherapy Combined With Tremelimumab and Durvalumab for BCLC Stage B and C Hepatocellular Carcinoma
Led by Chang Gung Memorial Hospital · Updated on 2025-09-10
45
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment including proton radiotherapy with the drugs tremelimumab and durvalumab for patients with unresectable hepatocellular carcinoma (HCC) at intermediate to advanced stages. This phase II trial aims to assess the safety, effectiveness, and immune effects of this combined approach since current therapies show limited response rates. Proton radiotherapy offers precise targeting with less damage to healthy tissue, and early data suggest that combining it with immune checkpoint inhibitors may improve tumor response. Participants will receive proton radiotherapy with doses adjusted based on tumor location and size: 72.6 CGE in 22 fractions for tumors close to vital organs and 66 CGE in 10 fractions for more distant tumors. Tremelimumab will be given as a single intravenous infusion of 300 mg, while durvalumab will be administered intravenously every 4 weeks at 1500 mg. Treatment duration with durvalumab depends on response, continuing up to two years for complete or partial responders and shorter for stable disease. During the study, participants will undergo regular clinical assessments including evaluation of progression-free survival over 12 months as the primary outcome. Other measures include tumor control, time to progression, overall response rate, survival, and monitoring of adverse events within one year. Patients will be monitored closely for safety and treatment effects throughout, with a total participation period aligned with these outcome assessments.
CONDITIONS
Brief 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 unsuitable for surgery or transplant, with tumor size limits
- Age 18 years or older
- ECOG performance status 0 or 1
- Barcelona Clinic Liver Cancer (BCLC) stage B or C
- Child-Pugh score 5-6 within 28 days before registration
- Documented hepatitis B and hepatitis C status
- Ability to understand and sign informed consent
- Adequate bone marrow, liver, and kidney function within 4 weeks before registration, including hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,000/mm3, platelet count ≥ 50,000/µL, total bilirubin < 2.5 mg/dL, serum albumin > 2.8 g/dL, ALT and AST ≤ 3 times upper limit of normal, prothrombin time ≤ 6 seconds prolonged, 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 overlapping planned liver treatment area
- Prior selective internal radiotherapy or hepatic arterial yttrium therapy
- Untreated active hepatitis B or C
- Moderate to severe or uncontrollable ascites
- Distant metastases not treatable by proton radiotherapy
- Untreated or incompletely treated esophageal or gastric varices
- Severe active co-morbidities including recent unstable angina, heart failure, myocardial infarction, infections requiring IV antibiotics, recent bleeding, bleeding or clotting disorders, or uncontrolled psychotic disorders
- Pregnancy or unwillingness to use contraception if of childbearing potential
- Prior solid organ transplantation
- Prior or active autoimmune diseases including various specified conditions
- Prior or active thrombotic or bleeding disorders, significant cardiac disease, or gastrointestinal perforation
- Inability to treat all disease sites with proton radiotherapy due to extensive metastases or large tumors
- Known HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years depending on treatment response
Participants receive proton radiotherapy combined with Tremelimumab and Durvalumab. Proton radiotherapy is delivered in 10 to 22 fractions depending on tumor location. Tremelimumab is given as a single IV infusion. Durvalumab is given by IV infusion every 4 weeks, with treatment duration varying based on response, lasting up to two years.
Multiple visits corresponding to radiotherapy sessions and durvalumab infusions every 4 weeks
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
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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