BCLC stage C の進行肝細胞癌を対象とした ソラ …

1 1 JSTHAECRG (Japan Society of transcatheter Hepatic arterial Embolization Clinical Research Group) JSTHAECRG-2013-01 (HCC-Sorafenib+TACEII) BCLC stage C TACE II Phase II trial of Sorafenib combined with on-demand Transarterial Chemoembolization for Advanced Hepatocellular Carcinoma (Barcelona Clinic Liver Cancer stage C): STAB study IVR IVR 464-8681 1-1 TEL 052-762-6111 FAX 052-764-2966 E-mail 2013 4 12 Version 2013 5 3 Version 2013 5 11 Version 2013 6 7 Version 2013 7 18 Version 2013 7 29 Version 2 0.

2 BCLC stage C (TACE) II BCLC stage C TACE Primary endpoint: Secondary endpoints: 1) 2) 3) 4) 20 5) BCLC- stage C Vp3, 4 6) 7) ECOG Performance Status 0 1 8) 9) Child-Pugh A score 5-6 10) 4 2 11) 8 12) TACE (day 1)

3 Day 4-28 TACE TACE 7-28 TACE 3 1st TACE 2nd TACE Sorafenib 800mg/day Sorafenib 800mg/day Day 1 Day 4-28 7-28 days 3 R 1 400mg 1 2 TACE TACE 2 1st TACE day 1 32 2 1 3 4 1. 7 2. 7 3.

4 12 4. 14 5. 15 6. 21 7. 22 8. 24 Case Report Form: CRF CRF 9. 25 5 10. 26 11.

5 27 Modified RECIST 12. 29 13. 30 IRB 14. 32 15. 32 16. 33 17. 34 6 (CRF) Common Terminology Criteria for Adverse Events - JCOG (CTCAE - JCOG) Modified RECIST RECISTver 7 1.

6 BCLC stage C TACE Primary endpoint: Secondary endpoints: 2 5 3 (1) 34,000 4 (2) 95% C (68%) B (15%) (3) 2 III (4) III (5)

7 5-FU+ 5-FU+ (6-9) PS Barcelona Clinic Liver Cancer (BCLC) staging system PS0 4 3cm Intermediate stage ( stage B) PS1-2 advanced stage ( stage C) (10) SHARP trial: Sorafenib Hepatocellular carcinoma Assessment Randomized Protocol (4) Asia-Pacific trial (5) BCLC advanced stage ( stage C) 8 BCLC stage B or C Drug eluting beads (DEB) II (11) BCLC stage B III (12)

8 BCLC stage C BCLC stage C II 1 BCLC staging system, 2008 (13) Very early stage (0) < 2cmIntermediate stage (B) PS 0 Early stage (A) PS 0 < 3cm, 3 Advanced stage (C) PS 1-2 End stage (D) stage 0PS 0 Child-Pugh AStage A-CPS 0-2 Child-Pugh A-BStage DPS > 2 Child-Pugh C 3cm , 3 PEI / RFA PS: Performance statusPEI: RFA: 5 40-70%3 10-40% < 3 1)

9 Raf c-Raf b-Raf MAP p38 VEGFR-2 VEGFR-3 PDGFR- Flt3 c-kit MAP VEGFR-2/PDGFR- 9 137 II Grade3-4 Child-Pugh A B III III SHARP trial: Sorafenib Hepatocellular carcinoma Assessment Randomized Protocol 22 2008 Llovet (4) Child-Pugh A 602 1 400mg 1 2 800mg/ 95% CI p< : 95% CI p< Grade 3 CTCAE ver.

10 11% 2% CTCAE ver 8% 1% III Asia-Pacific trial (5) : p= : p< I 27 I (14) Child-Pugh A B DLT 1 1 400mg 1 2 800mg/ 2009 5 2 (95% ) p SHARP trial 299 303 ( ) < ( )