Prospective cohort of primary liver tumours treated with pencil-beam scanning protontherapy (PROton therapy for LIver Tumours - PROLIT). - PROLIT

Apollo Proton Cancer Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Adult patients 18years or older with histological or radiologic diagnosis of hepatocellular carcinoma, intrahepatic cholangiocarcinoma or mixed histology
•2. Patients either deemed unresectable and/or locally recurrent OR who require bridging/down staging to orthotopic liver transplant OR who have tumour recurrence in a transplanted liver OR patients with any macrovascular invasion (tumour thrombosis of main portal vein, branch portal vein, segmental portal vein or hepatic vein, inferior vena cava).
•3. Patients must have normal organ and marrow function as defined below:
•a. Absolute neutrophil count >=750 cells/Î¼L
•b. Platelets >= 50,000 / Î¼L
•c. Total bilirubin <= 4 times the institutional upper limit of normal
•d. Transaminases (AST/ALT) <= 6 times the institutional upper limit of normal.
•e. Serum creatinine <= 2 mg/dl.
•4. Patients who have the ability to understand and be willing to sign a written informed consent document

•1. Patients with extra hepatic disease (M1) except oligometastatic disease and intravascular tumour thrombosis.
•2. Patients with more than 7 tumours, except closely conglomerated lesions/satellite lesions.
•3. Performance status of ECOG 3 or more.
•4. Patients with Child Pugh score 10 or more, i.e. Child- Pugh Class C, except if patient is on anti-coagulant like warfarin.

发起方

Apollo Proton Cancer Centre