The efficacy of stereotactic body radiation therapy for unresectable hepatocellular carcinoma: a single institution phase II study

Asan Medical Center0 个研究点目标入组 50 人开始时间: 待定最近更新: 2019年4月23日

试验速览

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•1. Liver function as Child-Pugh class A
•2. an Eastern Cooperative Oncology Group (ECOG) score: 0-1
•3. the HCC lesions were not suitable for surgery or percutaneous ablative therapies
•4. the HCC was = 6 cm across its longest diameter, or = 3 lesions were present with the sum of longest diameters = 6 cm
•5. an adequate residual functional liver volume was evident (> 700 mL)
•6. Women with childbearing potential and men must agree to use adequate contraception prior to study entry and during study participation
•7. The patient must give written, informed consent

•1. Liver function as Child-Pugh class B or C
•2. ECOG performance status?>1
•3. the HCC was > 6 cm across its longest diameter, or > 3 lesions were present
•4. Presence of major vascular invasion or extrahepatic metastasis
•5. AST or ALT >5 X upper normal limit (200 IU/L)
•6. no adequate residual functional liver volume due to liver cirrhosis or previous hepatic resection (< 700 mL)
•7. No sufficient distance between the HCC and adjacent organs at risk, such as the duodenum, stomach, colon, and spinal cord (< 1cm)
•8. Uncontrolled ascites or hepatic encephalopathy
•9. prior history of external beam radiotherapy in upper abdomen
•10. prior history of liver transplantation
•11. History of active gastro-duodenal ulcers within the past 3 months
•12. Pregnancy or breastfeeding. Patients don't agree to use adequate contraception
•13. Previous or concurrent cancer that is distinct in primary site or histology from HCC, except skin cancer within 5 years
•14. Any active clinically serious infections (Grade 3, CTCAE ver 4.0)
•15. Patients who don't agree to written, informed consent

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