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

  • Total Beds1,342
  • Total Doctors899
  • Address6F, No.35, Siao-Dong Road,North,Tainan City 704
  • ContactHSIN-PIN TU, Administrative Assistant of NCKUH CTC
  • Emailn123987ctc@gmail.com
  • Phone Number06-2353535#4691
Link to Hospital Link to Clinical Trial Center

1. Having Early Phase unit equipment and much experience in early phase trials , including 506 Phase I-II early phase trials.

2. Have a team of Clinical Research Nurse and complete grade classification.

3. Provide one-stop project matching and management service.

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

Chloe Orkin et al(2024). Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. All Science Journal Classifications, 11(2), 75-78. https://doi.org/10.1016/S2352-3018(23)00258-8

2

Margaret A. Tempero, et al(2023). Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial. Journal of Clinical Oncology, 41(11), 2007-2019. https://doi.org/10.1200/JCO.22.01134

3

Shubham Pant, et al (2023). Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study. The Lancet Oncology, 24(8), 925-935. https://doi.org/10.1016/S1470-2045(23)00275-9

4

R K Kelley,et al(2023). Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 401(1391), 1853-1865. https://doi.org/10.1016/S0140-6736(23)00727-4

5

A. T.C. Chan, et al(2023). Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Annals of Oncology, 34(3), 251-261. https://doi.org/10.1016/j.annonc.2022.12.007

6

S Y Rha, et al(2023). Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. The Lancet Oncology, 24(11),1181-1195. https://doi.org/10.1016/S1470-2045(23)00515-6

7

Z Ren, et al(2023). Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer, 12(1), 72-84. https://doi.org/10.1159/000527175

8

Sara A. Hurvitz, et al (2023). Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. The Lancet, 401(10371),105-117. https://doi.org/10.1016/S0140-6736(22)02420-5

9

M Simonelli, et al(2022). Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study. ESMO Open, 7(5), 100562. https://doi.org/10.1136/jitc-2021-003697

10

Peter Schmid, et al(2022). Abstract PD10-03: BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC): Results from Arm 1 D+ paclitaxel. Cancer Research, 82, PD10-03. https://doi.org/10.1158/1538-7445.SABCS21-PD10-03

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