1. To advance early or late phase trials of adjuvant therapy, neoadjuvant therapy, salvage therapy, and surgery clinical trials.
2. To establish the SOPs for clinical informatics and specimen collection of pancreatic, gastroesophageal, and biliary tract cancers and developed the UGI big bio-databases for data management and visualization and thereby facilitate the clinical trials.
3. From improved chemotherapy to precision medicine, we are currently launching International Collaborative Research Programs aimed to develop novel therapeutic strategies based on targeted, gene-, nano-, cell-, and immuno-therapies or emerging medication, biomedical materials/modalities, or multimodal artificial intelligence, etc.
1-1. We have performed more than 100 cancer clinical trials of international pharmaceutical companies. We have regular meetings with CROs from American, France, Switzerland, Denmark, Japan, and South Korea to make effective communication among PIs and hospital care team members.
1-2. The number of cases recruited in the NAPOLI-1 trial was the highest in the world, and two hospitals received FDA inspection (NCKUH and VGHTPE).
1-3. After facilitating the completions of clinical trials, we can increase the reputation of Taiwan in UGI cancers consortium in the world.
2-1. With continued success of new drug clinical trials, our endeavor could reduce health insurance expenditures and reduce financial burdens.
2-2. We have conducted more than 30 early phase clinical trials sponsored by domestic pharmaceutical manufacturers including PharmaEngine, OBI pharma, Senhwa Biosciences, TTY Biopharm, Golden Biotechnology, AP Biosciences, INNOPHARMAX, and TaiRx. PIs are invited by sponsor to evaluate the feasibility of new drug programs every year.
2-3. We have assisted the completion of the third phase clinical trial (NAPOLI-1) which is the first new cancer drug approved by the US FDA in the history of new drug development in Taiwan. It is also the top ten new drug sales champion in Taiwan and has contributed approximately TW$10.11 billion to global pharmaceutical market in 2022.
3-1. Our endeavor can recruit patients (N>5600) receive new treatment in medical centers, and patients can receive comprehensive treatment and thereby obtain better medical care quality.
3-2. We can help patients to understand the different regimens in different hospitals to improve patients’ outcome after received suitable treatment regimens from trials. We also help patients to obtain compassionate treatment and thereby reduce their financial burden and stress.
3-3. Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is approved for patients with metastatic pancreatic cancer, which can significantly improve overall survival compared with 5-FU/LV alone (11.6 vs. 5.5 months), with approximately 10% of patients surviving beyond 20 months. This combination regimen has an acceptable safety profile and generally manageable AEs, while maintaining quality of life over time versus 5-FU/LV alone.
4-1. We execute more than 50 global, 10 local, and 12 IIT clinical trials including new and continuation cases.
4-2. To create a clustering effect and engage more PIs or hospitals to join us via regularly hold UGI-TCTC meetings, consensus camps, or conferences every year, and invite domestic and foreign experts/scholars to conduct clinical practice or academic research exchanges and experience sharing with TCTC PIs and their research teams.
4-3. Our research results will be published in more than 10 international journals and at least 3 conference/symposium presentations every year.