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

  • Total Beds1,343
  • Total Doctors801
  • Address6F, No.35, Siao-Dong Road,North,Tainan City 704
  • ContactChen Chia-Hui
  • Emailn122980@ mail.hosp.ncku.edu.tw

1. Early Phase Unit (Also experienced in First In Human studies)

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

3. About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials.

Site Introduction

The NCKUH CTC serves as a platform for clinical trial management and support. There are experienced investigators, study coordinators and administrative assistants to provide various help to clinical trials also ensure the trial quality.

Services provided as:

  1. Phase I~III industry-sponsored clinical trials for medications, medical devices etc.
  2. Supporting to investigator-initiated trials.
  3. Various training program for medical professionals.
  4. Project managements, including:
    • Contact window of study feasibility
    • Matching potential PI.
    • Manpower support-- Study coordinator/ administrative assistant
    • Contract /Budget management.

Clinicl Trial Expertise

Oncology (lung cancer, liver cancer, Upper GI, Hematology, Solid Tumors, Urinary tract, Gynecology) 、Gastroenterology、 Cardiology、 Endocrinology、Neurology、 Rheumatology、 Psychiatry、 Dermatology….

International Accreditation

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 Inspection/audit

No critical issues from Audit and Inspection

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

What types of clinical trial do you conduct?

Spotlights

CTC

Publications

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

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.