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成大醫院臨床試驗中心Clinical Trial Center National Cheng-Kung University Hospital

  • 病床總數1,343
  • 醫師人數801
  • 地址704臺南市北區小東路35號6樓
  • 聯絡人陳嘉惠
  • 電子信箱n122980@ mail.hosp.ncku.edu.tw

1. 早期臨床試驗中心

2. AAHRPP /CAP/TAF認證

3. 執行約930多件臨床試驗,包括273件第一、二期之早期臨床試驗。

臨床試驗中心簡介

國立成功大學醫學院附設醫院臨床試驗中心為支持及管理臨床試驗的服務平台,有專業的試驗主持人、研究護理師和行政人員提供臨床試驗服務,以協助啟動臨床試驗及確保臨床試驗質量。

提供服務包括:

  1. 藥物、醫療器材之各期臨床試驗。
  2. 支持研究者發起臨床試驗。
  3. 提供臨床試驗教育訓練。
  4. 提供臨床試驗管理
    • 研究可行性評估連絡窗口。
    • 媒合臨床試驗主持人。
    • 研究護理師/行政人力支援。
    • 臨床試驗合約/預算管理。

臨床試驗重點領域

腫瘤(肺癌,肝癌,上消化道癌,血液腫瘤,實體腫瘤,泌尿癌,婦癌), 腸胃肝膽,心血管,內分泌,神經,風濕免疫,精神,皮膚…

國際認證

Accreditation

  • Full Accredited from the Association for the Accreditation of Human Research Protection Program (AAHRPP)
  • Pharmacogenomics laboratory received accreditations from the Taiwan Accreditation Foundation (TAF)
  • Pharmacogenomics laboratory received accreditations from the College of American Pathologists (CAP)

Training and Education

  • Yearly trained with GCP and ACRP accreditation current regulation

GCP查核

No critical issues from Audit and Inspection

  • Audits by the pharmaceutical companies and CROs.
  • Inspections by TFDA, FDA

卓越亮點

CTC

近年文獻發表

CTC

1

First-in-Human Phase I Study of Fisogatinib (BLU-554) Validates Aberrant Fibroblast Growth Factor 19 Signaling as a Driver Event in Hepatocellular Carcinoma. Cancer Discov. 2019 Oct 1. pii: CD-19-0555. doi: 10.1158/2159-8290.CD-19-0555.

2

Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198243. doi: 10.1001/jamanetworkopen.2019.8243.

3

3. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):282-296. doi: 10.1016/S1470-2045(18)30937-9..

4

Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bioradiotherapy in high-risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial. Head Neck. 2019 Jun;41(6):1703-1712. doi: 10.1002/hed.25640.

5

Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design. Future Oncol. 2019 Feb;15(6):567-577. doi: 10.2217/fon-2018-0668.

6

Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Aug 22. doi: 10.1158/1078-0432.CCR-19-1126.

7

Tuberculosis infection and lung adenocarcinoma: Mendelian randomization and pathway analysis of genome-wide association study data from never-smoking Asian women. Genomics. 2019 Jul 12. pii: S0888-7543(19)30112-0. doi: 10.1016/j.ygeno.2019.07.008.

8

A phase 1, open-label, dose-escalation trial of oral TSR-011 in patients with advanced solid tumours and lymphomas. Br J Cancer. 2019 Jul;121(2):131-138. doi: 10.1038/s41416-019-0503-9.

9

Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7.

10

Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Oct 4. pii: S1470-2045(19)30634-5. doi: 10.1016/S1470-2045(19)30634-5.