Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion
NCT ID: NCT05625893
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2023-01-15
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PBT arm
PBT and atezolizumab/bevacizumab
Atezolizumab 1200 mg and bevacizumab 15 mg/Kg is administered IV infusion every 3 weeks.
Proton beam therapy 30 - 50 Gy/5 fractions to portal vein tumor thrombosis with or without main primary tumor after 1 week (+/- 7 days) of 2nd cycle of atezolizumab and bevacizumab
The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.
Interventions
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PBT and atezolizumab/bevacizumab
Atezolizumab 1200 mg and bevacizumab 15 mg/Kg is administered IV infusion every 3 weeks.
Proton beam therapy 30 - 50 Gy/5 fractions to portal vein tumor thrombosis with or without main primary tumor after 1 week (+/- 7 days) of 2nd cycle of atezolizumab and bevacizumab
The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.
Eligibility Criteria
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Inclusion Criteria
1. Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022
2. Age \>= 20
3. Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
4. Signed written informed consent
5. at least one or more measurable intrahepatic viable HCC lesions
6. Child-Pugh class A within 2 weeks from screening for study registration
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration
8. Life expectancy of at least 16 weeks
9. adequate bone marrow and liver function within 2 weeks from screening for study registration
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count (ANC) ≥ 1,000/mm3
* Platelet count ≥ 50,000/μL
* Total bilirubin \< 2.5 mg/dL
* Serum albumin \>2.8 g/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN)
* Prothrombin time in INR ≤ 1.8 × ULN
* Serum creatinine ≤ 1.5 mg/dL
10. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the informed consent form until at least 6 months (women) and 7 months (men) after the last study drug administration
Exclusion Criteria
Patients with HCC meeting all of following criteria;
1. previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded.
2. any type of anticancer agent (including investigational) within 2 weeks before enrollment
3. Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy
4. Moderate to severe or intractable ascites
5. A history or presence of hepatic encephalopathy
6. Presence of active bacterial infection
7. Untreated active chronic hepatitis B or active hepatitis C
8. History of portal hypertension with bleeding within the past 6 months
9. Prior liver transplant
10. Uncontrolled severe medical comorbidity
11. unhealed wound
12. uncontrolled electrolyte imbalance
13. Non-interruptible therapeutic use of anticoagulants or thrombolytics
14. History of uncontrolled or autoimmune disease, or immunocompromised
15. interstitial lung disease
16. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
17. Mentally retarded/medically incapable of consent
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Jeong Il Yu
Assistant Professor
Principal Investigators
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Jeong Il Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PORTAL
Identifier Type: -
Identifier Source: org_study_id