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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
  • ContactTzu-Mei Weng
  • Emailn123987ctc@gmail.com
Link to Hospital Link to Clinical Trial Center

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

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.

2

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.

3

Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028.

4

The Influence of Prediagnosis Alcohol Consumption and the Polymorphisms of Ethanol-Metabolizing Genes on the Survival of Head and Neck Cancer Patients. Cancer Epidemiol Biomarkers Prev. 2019 Feb;28(2):248-257. doi: 10.1158/1055-9965.EPI-18-0425. Epub 2018 Oct 1.

5

Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326.

6

Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X.

7

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137.

8

Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials. J Glob Oncol. 2018 Jul;4:1-12. doi: 10.1200/JGO.17.00227.

9

Corrigendum to 'Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: Patient-focused outcome results from the randomised phase III REACH study' [Eur J Canc 81 (2017) 17-25]. Eur J Cancer. 2018 Sep;100:135-136. doi: 10.1016/j.ejca.2018.06.002.

10

Phase II Studies with Refametinib or Refametinib plus Sorafenib in Patients with RAS-Mutated Hepatocellular Carcinoma. Clin Cancer Res. 2018 Oct 1;24(19):4650-4661. doi: 10.1158/1078-0432.CCR-17-3588.

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