Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion

Launched by SAMSUNG MEDICAL CENTER · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced liver cancer, specifically those whose cancer has invaded the portal vein, which is a major blood vessel in the liver. The treatment combines proton beam radiotherapy—a type of precise radiation therapy—with two medications called Tecentriq (atezolizumab) and Avastin (bevacizumab). The main goal is to see how well this combination works in stopping the cancer from progressing, as well as to evaluate its safety.

To be eligible for this trial, participants must be at least 20 years old and have a confirmed diagnosis of hepatocellular carcinoma (the most common type of liver cancer) with specific portal vein involvement. They should also have measurable cancer in the liver and meet certain health criteria, including good liver function and no previous systemic treatment for liver cancer. If you join the study, you will receive this new treatment and be monitored closely for its effects. This trial is currently recruiting and welcomes patients of all genders. If you or a loved one are considering participation, it's important to discuss all options and any questions with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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