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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05625893
Other study ID # PORTAL
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 16, 2022
Est. completion date December 31, 2025

Study information

Verified date November 2022
Source Samsung Medical Center
Contact Jeong Il Yu, MD, PhD
Phone 82-2-3410-9598
Email ro.yuji651@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is investigator initiated, single-institution, prospective, phase 2 open-label study to determine the efficacy and safety of combination therapy of atezolizumab/bevacizumab and proton beam therapy to portal vein tumor thrombosis with or without main primary tumor in patients with stage 3 or higher hepatocellular carcinoma (HCC) with Vp2-4 portal vein invasion who had not undergone systemic therapy for HCC. The primary endpoint of this study is progression-free survival and secondary endpoints are overall survival (OS), time to progression (TTP), objective response rate, disease control rate (DCR), and time to local disease progression (LTP).


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date December 31, 2025
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Patients with HCC meeting all of following 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 11. If other selection conditions are satisfied and the exclusion criteria are not met, registration is possible even in case of N1 or M1. 12. Registration is possible even in the case of hepatic vein tumor infiltration if other selection conditions are satisfied and the exclusion criteria are not met 13. no limitation according to the size and number of tumors in the liver. 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

Study Design


Intervention

Radiation:
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.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival rate At 9 month
Primary Incidence of adverse event assessed according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) From date of atezolizumab and bevacizumab initiatton until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Secondary Overall survival rate At 12 month
Secondary Time-to-progression At 9 months
Secondary Objective response rate At 3 month
Secondary Disease Control rate At 3 month
Secondary Local tumor progression rate At 12 month
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