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臺大醫院臨床試驗中心National Taiwan University Hospital Clinical Trial Center

  • Total Beds2,106
  • Total Doctors570
  • Address7 Chung Shan S. Rd.,Zhongzheng,Taipei City 100
  • ContactSin-Jie Lin
  • Emaillinsinjie@ntuh.gov.tw

1. From 2023 to 2024, our team had three H. pylori-related studies published in the prestigious international journal "Lancet Gastroenterology and Hepatology," and all were selected for the respective issue's cover. 1. Utilizing shotgun metagenomics sequencing, we found that the resistome transiently increases two weeks after second-line H. pylori eradication but returns to pre-treatment levels by the eighth week and one year. (Published in March 2023) 2. Molecular testing-guided therapy for H. pylori infection in both first-line and third-line therapy showed non-inferior efficacy compared to traditional susceptibility guided therapy guided. The results support the use of molecular testing-guided therapy for precision treatment of H. pylori infection. (Published in July 2023) 3. Meta-analysis analysis revealed an increase trend in primary resistance rates of clarithromycin, levofloxacin, and metronidazole for H. pylori in various Asia-Pacific countries, while the resistance rates for amoxicillin and tetracycline remained stable. Significant heterogeneity in antibiotic resistance among Asian countries was observed. (Published in January 2024)

2. The Taiwan Breast Cancer Consortium (TBCC) conducted a collaborative study across multiple hospitals in Taiwan comparing the efficacy of whole-brain radiotherapy (WBRT) alone versus WBRT preceded by combination therapy with Bevacizumab, Etoposide, and Cisplatin in untreated breast cancer patients with brain metastases. The paper has been published in JAMA Oncology, with Dr. Yen-Shen Lu listed as the corresponding author. Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. Published online December 21, 2023. doi:10.1001/jamaoncol.2023.5456

3. Immune cell therapy, as a new field of cancer treatment, has been rapidly developing worldwide over the past decade. The Hematology Department at National Taiwan University Hospital (NTUH) has accumulated years of experience in cell therapy and early-phase clinical trials of drugs. They have established a clinical trial team for immune cell therapy and built a cell processing laboratory and clinical cell therapy center that meet clinical standards. They have actively engaged with many domestic biotech companies focused on developing cell therapies, from collaborating on preclinical product development to discussing details of early-phase clinical trial designs and execution, to conducting formal clinical trials. They aim to combine the clinical and industrial sectors to bring products to the clinical field to benefit patients. Both gene-unmanipulated adoptive cell therapy (ACT) and gene-manipulated chimeric antigen receptor T-cell therapy (CAR-T) are the research targets of NTUH's immune cell therapy clinical trial team. The team will focus on the further clinical development of immune cell therapy in NTUH and Taiwan. The main directions include the following:A. Collaborative research and development of cell processes before clinical trials. B. Implementation of clinical trials for cell therapy. C. Establishment of Clinical Field for Cell Therapy. Since 2020, our project has embarked on a collaborative journey with both domestic and international biotech industries, initiating with preclinical research and progressively expanding into multinational clinical trials of CAR-T cell therapy, encompassing Phase I/II and Phase III studies. Over the past four years, we have conducted a total of 141 CAR-T clinical trials in collaboration with five biotech and pharmaceutical companies worldwide, comprising 131 preclinical studies, 8 Phase I/II trials, and 2 Phase III trials. Notably, two CAR-T drugs developed in partnership with domestic biotech enterprises are preparing to commence Phase I clinical trials in the third quarter of this year. Furthermore, leveraging Taiwan's pioneering role in cellular therapy research, along with our robust infrastructure and environment, National Taiwan University Hospital has been distinguished as the first medical center in Taiwan to be certified by Novartis as a CAR-T center, offering the commercially available Kymriah for standard treatment. Since 2022, we have successfully completed 20 treatments, leading in the CAR-T cell therapy field in Taiwan.

Site Introduction

In recent years, the biotechnology development has always been the first priority for the national health care industry in Taiwan. However, as the most critical step in new drug development, human clinical trials in Taiwan have faced the bottleneck for the past few years because of the complexity and high costs.

In order to encourage the development of biotechnology industry and make up for the gap of downstream supply chian in new drug development process, National Taiwan University Hospital (NTUH) established the "National Center of Excellence for Clinical Trial and Research" in 2005 in response to the "Biotech Takeoff Diamond Action Plan" from the Executive Yuan, Republic of China (Taiwan) and played the leading role of biotechnology industry R&D and clinical implementation in Taiwan.

After focusing on innovative research and development strategies in clinical trials for these years, we have built a great clinical research environment and operating system, achieving distinctive results in doing new drug clinical trial research. In 2011, we won the 1st National Industrial Innovation Award in Taiwan. Besides, many international biotechnological pharmaceutical companies and clinical trial companies cooperated with NTUH to establish R&D centers in Taiwan because of the recognition for our innovative strategies and distinctive results. Combining global leading positions of international pharmaceutical companies in treatment areas of different diseases, our collaborations speed up new drug clinical research, benefiting patients around the world.

We conduct about 600 new drug clinical trials each year, including more than 40 new drug Phase I trials, including more than 40 international clinical trials. We hold positions of principal investigators and members of steering committee for international clinical trials. Now NTUH plays a leading role of clinical trials and research in the Asia Pacific Region and makes great contribution in the development and innovation of the biotechnology industry in Taiwan.

Clinicl Trial Expertise

Oncology, hematology, cell therapy, gastrointestinal tract disease, hepatology, rheumatology, metabolic disease, pulmonary disease, infectious disease, vaccine, cardiovascular disease, stroke, neurology, minimally invasive cancer surgery, early phase clinical trials.

International Accreditation

AAHRPP, FERCAP

GCP Inspection/audit

US FDA, PMDA, EMA

What types of clinical trial do you conduct?

Spotlights

CTC

The incidence and prevalence of acute kidney injury (AKI) have been increasing worldwide. Taiwan has been ranked first in the world in terms of the incidence and prevalence of end-stage renal disease requiring dialysis. No effective treatment for AKI has been developed. In our animal study, we confirmed that administering a demethylation drug (azacitidine) to animals after AKI could reduce the subsequent occurrence of kidney fibrosis and chronic kidney disease (CKD). Although azacitidine is currently FDA-approved and widely used to treat acute myeloid leukemia and myelodysplastic syndrome. The pharmacokinetics and safety in renal function impairment patient is unknown. Therefore, firstly, we designed clinical trial for the pharmacokinetics and safety in CKD patients, and we have included several patients in the study. Subsequently, we aim to utilize these findings to tailor treatment dosages for AKI, marking a significant advancement in the management of AKI.

 

Our team’s primary highlight is the C/EBPA therapy targeting myeloid-derived suppressor cells for treatment, which has been initiated in collaboration with Imperial College London based on research published by both institutions. The team has commenced a US-FDA clinical trial for new drug approval (MNA-3521-011: A First-in-Human, multi-center, open-label, Phase 1 Clinical Study using RNA Oligonucleotide Drug MTL-CEBPA to Investigate Safety and Tolerability in Patients with Advanced Liver Cancer). Professor Huang Kai-Wen, the principal investigator for the Asia-Pacific region, completed the first phase of the clinical trial in 2020, with results published in Clinical Cancer Research (MTL-CEBPA, a Small Activating RNA Therapeutic Upregulating C/EBP-α, in Patients with Advanced Liver Cancer: A First-in-Human, Multicenter, Open-Label, Phase I Trial. Clinical Cancer Research. 2020). Currently, a multi-national, multi-center phase II clinical trial is underway. Additionally, another USFDA clinical trial using the same drug in combination with immunotherapy to treat all solid tumors is also being conducted in multiple countries and centers, with our team serving as the principal investigator for the Asia-Pacific region. (MNA-3521-012: An open label phase 1a/b study of MTL-CEBPA in combination with a PD-1 inhibitor).

 

TCTC-Liver consortium has successfully attracted and participated in 28 clinical drug trials led by major international pharmaceutical companies; 13 clinical drug/medical devices trials led by domestic pharmaceutical companies or biotechnology companies; and successfully promoted 8 clinical drug trials hosted by Clinical trials of drugs initiated by people. We conduct phase III global multi-center clinical trial “Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection” to develop new treatment strategies for combined hepatitis B and hepatitis C patients. The results of its research and development were published in the internationally renowned journal Gastroenterology and assisted manufacturers in obtaining new indications for HCV treatment (Genotype 2), assists in HCV elimination.

 

Facilitate the licensure of first domestically developed vaccine- A multi-national and multi-center phase 3 enterovirus 71 vaccine in young infants and children

 

Lung cancer is an important health issue in Taiwan, and the shift in treatment approaches from late-stage to early-stage cancer has become a global trend. The promotion and widespread adoption of low-dose computed tomography (LDCT) have led to an annual increase in the number of lung cancer cases eligible for surgery, further accelerating this transition. Therefore, early-stage lung cancer management, including surgical intervention and personalized adjuvant therapy, plays a crucial role in overall lung cancer care. Through the efforts of our clinical trial team, we have spearheaded numerous clinical trials in lung cancer. This includes a phase III, double-blind, randomized, placebo-controlled, international trial evaluating the efficacy and safety of adjuvant Osimertinib compared to a placebo in participants with completely resected tumors and positive epidermal growth factor receptor (EGFR) mutations in stage IA2-IA3 non-small cell lung cancer (ADAURA2). A total of 380 participants from approximately 200 trial centers across about 25 countries were enrolled, with 70 participants from Taiwan involved in the trial. Our institution recruited 29 participants, making it the hospital with the highest enrollment globally.

 

We participated in the early clinical trial design and implementation of the Medigen COVID-19 vaccine development. The Medigen protein vaccine has been authorized for emergency use in Taiwan FDA and has been available for public vaccination. The trial results were published in Lancet Respiratory Medicine and received international recognition (including a published interview in the journal Nature). It was also selected by the WHO and the Bill & Melinda Gates Foundation for sponsorship in the third phase of the trial. The technology transfer license was granted to the WHO on August 30, 2023.

 

Our consortium actively integrates Taiwanese researchers to engage various important studies. First, through computed tomography, it has been shown that the new bioadaptive drug-eluting stent (Dynamx) outperforms traditional drug-eleuting stents in terms of restoration of vascular motion, and this drug-eluting stent has received FDA approval. Another study, SELECT trial, focuses on evaluating the effectiveness of Semaglutide in obese patients with cardiovascular disease, showing a 20% reduction in cardiovascular events. This is a groundbreaking finding that changes general perceptions of weight loss drugs.

Additionally, our consortium, in collaboration with the Graduate Institute of Photonics and Optoelectronics at National Taiwan Normal University, has developed the " Immune magnetic reduction testing technology", which can detect Alzheimer's disease early with just 6cc of blood. This technology is world leading and received marketing authorization from the Taiwan Ministry of Health and Welfare. Our consortium has also developed the world's first instrument for diagnosing coronary artery disease using multichannel electrocardiography and has received support from the National Science and Technology Council, promoting the development of related biotechnology industries.

On the other hand, our consortium has explored the use of locally developed novel active bamboo charcoal/probiotic therapy to reduce major adverse cardiovascular events by absorbing nephrotoxins in the intestine in chronic kidney disease patients. Moreover, our consortium has conducted over 90 clinical trials, establishing a comprehensive database regarding blood lipid profile and arteriosclerosis-related diseases, providing important references for the treatment of related diseases in Taiwan. Based on these research findings, Taiwan's reimbursement criteria for lipid-lowering drugs and new lipid treatment guidelines have been updated. Our goal is to reduce cardiovascular events and lower medical expenses in the future.

Publications

CTC

1

MTL-CEBPA, a Small Activating RNA Therapeutic Upregulating C/EBP-α, in Patients With Advanced Liver Cancer: A First-in-Human, Multicenter, Open-Label, Phase I Trial.

2

Prognostic effect of high-density lipoprotein cholesterol level in patients with atherosclerotic cardiovascular disease under statin treatment

3

Prognostic Factor Analysis of Irreversible Electroporation for Locally Advanced Pancreatic Cancer - a multi- institutional clinical study in Asia.

4

Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study

5

Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis

6

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

7

Molecular testing-guided therapy versus susceptibility testing-guided therapy in first-line and third-line Helicobacter pylori eradication: two multicentre, open-label, randomised controlled, non-inferiority trials

8

Second-line levofloxacin-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication and long-term changes to the gut microbiota and antibiotic resistome: a multicentre, open-label, randomised controlled trial

9

Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial

10

Low-Dose Computed Tomography screening in relatives with a family history of lung cancer