Proton beam radiotherapy followed by Tecentriq(R) amd Avastin(R) for primary liver cancer with protal vein Invasio

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008001
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Signed written informed consent
2.over 20 years of age
3.Histologically confirmed hepatocellular carcinoma(HCC)
4.at least one or more measurable intrahepatic viable HCC lesions by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI)
5.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(portal vein, hepatic vein, and/or inferior vena cava)
2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
6.Child-Pugh class A
7.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
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

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.Active hepatitis B infection status, untreated active chronic hepatitis B or active hepatitis C infection
8.History of portal hypertension with bleeding within the past 6 months
9.Prior liver transplant
10.Uncontrolled severe medical comorbidity(Active tuberculosis, acute infection, acute ischemic heart disease, peptic ulcer disease)
11.Unhealed wound from surgery and other trauma
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

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate, Incidence of adverse event assessed according to the Common Terminology Criteria for Adverse Events

Secondary Outcome Measures

Name	Time	Method
Overall survival rate, Time-to-progression, Objective response rate, Disease Control rate, Local tumor progression rate