BCLC stage C の進行肝細胞癌を ... - …

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. bclc stage C (TACE) II bclc stage C TACE Primary endpoint: Secondary endpoints.

2 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) 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.

3 7 2. 7 3. 12 4. 14 5. 15 6. 21 7. 22 8. 24 Case Report Form: CRF CRF 9. 25 5 10. 26 11. 27 Modified RECIST 12. 29 13. 30 IRB 14.

4 32 15. 32 16. 33 17. 34 6 (CRF) Common Terminology Criteria for Adverse Events - JCOG (CTCAE - JCOG) Modified RECIST RECISTver 7 1. 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) 5-FU+ 5-FU+ (6-9)

5 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) 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)

6 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) 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.

7 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 ( ) < ( ) < 10 Asia-Pacific trial 150 76 ( ) ( ) II 137 I 27 ( ) transcatheter arterial chemoembolization.

8 TACE C bclc stage B 1 2 50 (15) Child-Pugh C Vp3 Vp4 Vp3 Vp4 16 4' DNA DNA RNA DNA DNA RNA C 11 DNA DNA DNA DNA DNA II 65mg/ m2 70ml 20-40 4-6 Miriplatin (MPT) ( )

9 [Iodized-oil (Lpd)] (17,18) (19) 2) + bclc stage C 1 400mg 1 2 II bclc stage B III 12 bclc stage C Primary endpoint Secondary endpoints 1045 3 12 67

10 65 45 bclc stage C 3 3. 1) 1 2) 2 3) 4) 20 5) bclc - stage C Vp3, 4 6) 3 7) 8) ECOG Performance Status 0 1 13 9) 14 Neutro 1,500/mm3 HGB PLT 60,000/mm3 T-Bil ALB AST 5 ALT 5 Amylase 2 Cre 10) Child-Pugh A score 5-6 11) 4 2 12) 8 13) 1) CT MRI wash out AFP PIVKA-II 2 2) 3) ( 3)