1. Multi-Center Clinical Trials
| TCOG has completed 57 trials (1 Breast Cancer, 6 Lymphoma, 2 Soft Tissue Sarcoma, 1 Lung Cancer, 5 Nasopharyngeal Carcinoma, 2 MALToma, 1 DLBCL, 5 Hepatocellular Carcinoma, 1 gastrointestinal tract Cancer, 3 Gastric Cancer, 2 Cervical Cancer, 6 Biliary Tract Cancer, 1 Prostate Cancer, 4 Oral Cavity Cancer, 3 Colorectal Cancer, 10 Pancreatic Cancer, 1 GIST, 1 NET, 1 GEP-NET, 1 CLL, 1 H&N Cancer) with total 9,237 enrolled cases throughout the pass years. In 2022, there are currently 14 active trials (1 Pancreatic Cancer, 2 GIST, 1 Hepatocellular Carcinoma, 2 Lung Cancer, 3 Lymphoma, 3 Esophagus Cancer, 1 GEP-NET, 1 Biliary Tract Cancer) with total 1,683 enrolled cases, 1,865 cases are still on-going treatment and 162 cases following-up the survival. Several new protocols will be opened and reviewed in near future. These clinical studies are listed as follows: |
|
On-Going Clinical Trials (update: Jun. 2022)
| No. | Protocol | PI | Date Activated | Expected Cases | Entered Cases |
|---|---|---|---|---|---|
| T1218 | The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry | Chun-Nan Yeh, Hui-Jen Tsai |
2018.10 ~ now | 3000 | 928 |
| T2219 | Atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma (HCC) and chronic hepatitis B virus (HBV) infection | Chiun Hsu | 2020.03 ~ now | 48 | 26 |
| T1519 | A Phase 2 trial of durvalumab (MEDI4736) and tremelimumab with chemotherapy in metastatic EGFR mutant non-squamous non-small cell lung cancer (NSCLC) following progression on EGFR Tyrosine Kinase Inhibitors (TKIs) (ILLUMINATE) | Chih-Hsin Yang, Hui-Jen Tsai |
2020.04 ~ now | 50 | 44 |
| T2420 | A Phase Ib Study of combining Rituximab, Acalabrutinib, and Durvalumab (RAD) in PCNSL. | Shang-Ju Wu | 2021.02 ~ now | 22 | 10 |
| T1521 | The Registry of Genetic Alterations of Taiwan Non-small Cell Lung Cancer | Chih-Hsin Yang, Nai-Jung Chiang |
2021.06 ~ now | 500 | 487 |
| T1221 | A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients (TOPICS-GIST) | Li-Tzong Chen, Hui-Jen Tsai |
2021.07 ~ now | 50 | 12 |
| T1220 | BI-754091 and Afatinib for Refractory Esophageal squamous cell carcinoma (BEAR study): a single-arm, phase II study | Ming-Huang Chen, Nai-Jung Chiang |
2021.08 ~ now | 44 | 28 |
| T2221 | A Phase I/II Study Using Cabozantinib and Lanreotide as Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors That Failed Molecular Targeted Therapies or Chemotherapy (SCALET) | Hui-Jen Tsai | 2021.10 ~ now | 49 | 6 |
| T3221 | The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer | Ming-Huang Chen, Nai-Jung Chiang |
2021.10 ~ now | 200 | 72 |
| T4221 | The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan | Chih-Hung Hsu, Shang-Hung Chen |
2021.10 ~ now | 400 | 50 |
| T1420 | A Phase I/II Study of Ruxolitinib, Paclitaxel, and Rituximab (RPR) in Patients with Relapse/Refractory Diffuse Large B-cell Lymphoma | Chih-Cheng Chen, Hui-Jen Tsai |
2021.11 ~ now | 74 | 1 |
| T5221 | A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination with S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer | Yung-Yeh Su | 2022.01 ~ now | 86 | 19 |
| T1421 | A Single-arm Phase Ib/II Study of the Combination of Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas | Wei-Li Ma, Hui-Jen Tsai |
2022.3 ~ now | 36 | 0 |
| T2220 | Randomised Phase III Controlled Trials of Regorafenib containing regimens versus standard care in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) | Li-Tzong Chen | 2022.3 ~ now | 40 | 0 |
Finished Clinical Trials
| No. | Protocol | PI | Date Activated | Entered Cases |
|---|---|---|---|---|
| T1188 | Phase II Study of Weekly CAF for Advanced Breast Cancer. | Wei-Shou Hwang | 1988.10 ~ 1994.12 | 107 |
| T1488 | Prospective Study of T and B Cell NHL by Using CHOP. | Ann-Lii Cheng | 1988.9 ~ 1994.12 | 213 |
| T1788 | Phase II Trial of VIP in Advanced Soft Tissue Sarcoma. | Wei-Shou Hwang | 1988.7 ~ 1994.12 | 90 |
| T1592 | Evaluation of Dose Optimization of Carboplatin for SCLC. | Jang-Yang Chang | 1992.2 ~ 1995.5 | 40 |
| T1394 | Phase III Study of R/T vs. CCRT in Advanced NPC. | Kwan-Hwa Chi | 1994.11 ~ 1999.7 | 158 |
| T1495 | Phase III Study of Steroid-containing vs. Steroid-free Chemotherapy for HBV Carriers with Non-Hodgkin’s Lymphoma. | Ann-Lii Cheng, Pei-Jer Chen |
1995.11 ~ 2000.5 | 50 |
| T1296 | Eradication of HP in the Management of Low-grade MALToma. | Li-Tzong Chen | 1996.3 ~ 1999.4 | 41 |
| A1293 | Gastric Adenocercinoma Registry in Surgery and Pathology. | Chew-Wun Wu | 1998.6 ~ 2000.12 | 1386 |
| T1297 | Phase III Adjuvant IFN vs Conservative Tx for Post OP HCC. | Li-Tzong Chen, Pei-Jer Chen |
1997.10 ~ 2003.4 | 268 |
| T1899 | HPV Survey in CIN for LSIL Cases. | Tang-Yaun Chu, Chi-An Chen, Tzer-Ming Chen |
1999.8 ~ 2004.2 | 1331 |
| T2201 | Phase III Study in PostOP Adjuvant CCRT for Stage III & IVa Adeno- carcinoma of Stomach. | Jang-Yang Chang | 2001.4 ~ 2004.3 | 14 |
| T1E01 | PostOP Adjuvant Therapy for Stage Ib-IIa Cervical Carcinoma with Pelvic LN Meta. | Chyong-Huey Lai | 2002.2 ~ 2004.3 | 4 |
| T1802 | Phase II THADO for Prostate Cancer. | Ruey-Kuen Hsieh | 2002.10 ~ 2004.7 | 30 |
| T3202 | Phase II Palliative C/T for Biliary Tract Cancer. | Chiun Hsu | 2002.7 ~ 2004.9 | 50 |
| T2399 | Phase III Adjuvant CCRT for High-risk Oral Cavity Cancer. | Mow-Ming Hsu, Ruey-Long Hong |
1999.8 ~ 2004.11 | 161 |
| T1401 | Phase III Oral Anti-HBV Prophylaxis for HBV Carrier with Non-Hodgkin’s Lymphoma. | Ann-Lii Cheng, Pei-Jer Chen |
2001.10 ~ 2005.4 | 52 |
| HNPCC | Heritable Colorectal Cancer Registry. | Reiping Tang | 2002.5 ~ 2006.12 | 817 |
| T1399 | Phase III Chemoprevention Tx vs Placebo for Oral Cavity Cancer. | Mow-Ming Hsu, Ruey-Long Hong |
1999.4 ~ 2005.7 | 342 |
| T2202 | Phase III Thado vs Placebo for Advanced HCC. | Li-Tzong Chen | 2003.2 ~ 2007.7 | 16 |
| T1202 | Phase II Adjuvant C/T for High-risk Colon Cancer. | Tsai-Shen Yang | 2002.4 ~ 2008.1 | 162 |
| T1204 | Phase II Induction C/T + CCRT for Locally Advanced Pancreatic Cancer. | Hui-Ju Ch’ang, Li-Tzong Chen |
2004.11 ~ 2008.8 | 50 |
| T1303 | Phase III Induction C/T +CCRT vs CCRT for Stage IV NPC. | Ruey-Long Hong, Mow-Ming Hsu, Cheng-Hsu Wang |
2003.8 ~ 2009.8 | 480 |
| T1405 | Phase II CCRT for NK T-cell Lymphoma. | Ming-Chih Chang | 2006.5 ~ 2009.9 | 33 |
| T1406 | Phase II High Dose MTX + Steroid and Whole Brain R/T with Temozolomide for CNS Lymphoma. | Ching-Hung Lin, Ann-Lii Cheng |
2006.11 ~ 2009.10 | 4 |
| T1706 | Phase II C/T with Gemcitabine & Docetaxel for Soft Tissue Sarcoma or GI Stromal Tumor. | Chung-Huang Chan | 2006.12 ~ 2010.1 | 58 |
| T1209 | Phase I/II sorafenib + thalidomide in HCC. | Chung-Huang Chan | 2009.8 ~ 2010.1 | 3 |
| T1206 | Phase III Adjuvant Oral Anti-HBV Tx for Post OP HCC. | Li-Tzong Chen, Pei-Jer Chen |
2007.4 ~ 2010.8 | 117 |
| T1309 | Phase II Study of Neoadjuvant Bio-C/T with CPC Followed by Bio-R/T in High-risk OSCC. | Jang-Yang Chang, Sen-Tien Tsai |
2009.9~2011.5 | 47 |
| T2207 | Phase II Trial Celecoxib with PreOP CCRT for Locally Advanced Rectal Cancer. | Ling-Wei Wang | 2007.7 ~ 2011.6 | 55 |
| T1210 | Randomized Phase II Study of GEMOX With or Without Cetuximab in BTC. | Li-Tzong Chen | 2010.12 ~ 2012.5 | 122 |
| T1306 | Phase II/III Adjuvant Anti-Angiogenesis Tx for High-risk Oral Cavity Cancer. | Ruey-Long Hong | 2007.5 ~ 2012.12 | 150 |
| T2209 | Phase II Randomized Study of C/T Followed by CCRT in Locally Advanced Pancreatic Cancer. | Hui-Ju Ch’ang, Yan-Shen Shan |
2009.11 ~ 2013.1 | 15 |
| T3211 | Phase II Study Using Genetic Polymorphisms of Drug in Patients with Gastric Cancer. | Yee Chao, Ming-Huang Chen |
2012.3 ~ 2014.11 | 51 |
| T2211 | Phase II Study of Weekly AUY922 for Advanced GIST. | Li-Tzong Chen, Nai-Jung Chiang |
2011.10 ~ 2015.2 | 29 |
| T3206 | Phase II Triple-Treatment for Low & High Grade MALToma. | Li-Tzong Chen | 2006.10 ~ 2015.5 | 47 |
| T3207 | Phase III Adjuvant Gemcitabine vs. Gemcitabine + CCRT in Pancreatic Cancer. | Tsann-Long Hwang, Hui-Ju Ch’ang |
2009.2 ~ 2015.7 | 147 |
| T1408 | Chemotherapy-Induced Hepatitis B Reactivation in Lymphoma Patients with Resolved HBV Infection: A Prospective Study. | Chiun Hsu | 2009.6 ~ 2011.12 2014.3 ~ 2015.12 |
154 + 48 |
| T1211 | Phase I/II Trial of SLOG Therapy in Metastatic Pancreatic Cancer. | Li-Tzong Chen, Kun-Chih Tsai |
2012.4 ~ 2015.12 | 73 |
| TG1308 | S-1 in Combination with Gemcitabine for Patients with Advanced Biliary Tract Cancer. | Li-Tzong Chen | 2015.5 ~ 2016.6 | 51 |
| T1313 | Phase III Trial in NPC with Post- radiation Detectable Plasma EBV DNA. | Jin-Ching Lin | 2014.12 ~ 2016.12 | 10 |
| T2312 | The Effect of EGCG on Virus Reactivation in Post- radiation NPC Patients without Detectable EBV DNA. | Jin-Ching Lin, Jen-Yang Chen, Sen-Tien Tsai |
2013.4 ~ 2017.10 | 353 |
| T3214 | Phase II Trial of LDK378 as Therapy in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma. | Li-Tzong Chen, Hui-Ju Ch’ang |
2015.9 ~ 2017.12 | 9 |
| T3212 | The Clinical Significance of Bio-markers in Pancreatic Cancer Patients. | Hui-Ju Ch’ang, Li-Tzong Chen |
2012.12 ~2018.3 | 270 |
| T1Z14 | Phase II Study of TLC388 as Second-line Treatment for poorly-differentiated NET Patients. | Yee Chao, Ming-Huang Chen, Hui-Jen Tsai |
2015.7 ~ 2018.5 | 23 |
| T2212 | Randomized Two Arms Phase II Study of Induction Chemotherapy Followed by CCRT in Locally Advanced Pancreatic Cancer. | Hui-Ju Ch’ang, Yen-Shen Shen |
2013.7 ~ 2019.1 | 55 |
| T1914 | Molecular Features Underlying Ethnic Differences in Survival of CLL Patients in Taiwan. | Hwei-Fang Tien, Shang-Ju Wu |
2015.11 ~ 2019.1 | 255 |
| T5217 | A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Unresectable or Metastatic Pancreatic Cancer | Li-Tzong Chen, Nai-Jung Chiang, Yen-Shen Shen |
2018.3 ~ 2019.11 | 130 |
| T2214 | First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL. | Sung-Hsin Kuo, Li-Tzong Chen |
2015.4 ~ 2020.3 | 17 |
| T1217 | Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine (GSL) in Elderly Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma | Li-Tzong Chen, Li-Yuan Bai |
2018.7 ~ 2020.3 | 49 |
| T1214 | Multi-center Registration Study for Gastroentero- Pancreatic NET in Taiwan | Li-Tzong Chen, Yen-Shen Shen, Hui-Jen Tsai |
2014.1 ~2020.4 | 600 |
| T2317 | Phase 2 Study of Nanoliposomal Irinotecan (nal-IRI, PEP02, MM-398, Onivyde®) with 5-FU and Leucovorin in Squamous Cell Carcinoma (SCC) of Head & Neck and Esophagus after Prior Platinum-based Chemotherapy or Chemoradiotherapy | Li -Yuan Bai, Nai-Jung Chiang |
2018.12 ~ 2020.5 | 59 |
| T1317 | Pembrolizumab for Nasopharyngeal Carcinoma Patients with Detectable Plasma Epstein-Barr Virus DNA but Without Clinically Detectable Residual Diseases and/or Metastases After Curative Chemoradiation – A Single Arm Phase II Trial | Hsiang-Fong Kao, Kwang-Yu Chang |
2019.1 ~ 2020.5 | 2 |
| T3217 | Phase II Randomized Trial of S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) vs Gemcitabine and Cisplatin (GC) in Locally Advanced or Metastatic Biliary Tract Cancer | Li-Tzong Chen, Nai-Jung Chiang |
2018.4 ~ 2020.6 | 92 |
| T1216 | An Open-Label Phase I, Dose-Escalation Study of Biweekly Abraxane in Combination with Oxaliplatin and Oral S-1/LV, the SOLAR Regimen, as First-line Chemotherapy in Patients with Advanced Gastric, Pancreatic and Biliary Cancers | Li-Tzong Chen | 2018.2 ~ 2020.11 | 19 |
| T1219 | A Study of Nivolumab combination Gemcitabine and S1 as First Line Treatment in Patients with Advanced Biliary Tract Cancer | Ming-Huang Chen, Nai-Jung Chiang |
2019.12 ~ 2020.12 | 48 |
| TG1709 | A phase II study of S-1 Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer in Taiwan | Li-Tzong Chen | 2019.07 ~ now | 36 |
| T2217 | Nivolumab plus ipilimumab as neoadjuvant therapy for hepatocellular carcinoma (HCC) | Chiun Hsu | 2019.1 ~ 2022.4 | 43 |
2. International Collaboration
TCOG has been the member of the Breast International Group (BIG) since 2006. TCOG provides consultation and coordination for BIG trials in Taiwan. Up to now, TCOG has participated in Six (HERA, NeoALTTO, ALTTO, APHINITY, PALLAS and Olympia) completed international cancer clinical trials of breast cancer, one trial (ALEXIMp030) is still on-going and several new protocols will be opened in near future.
The result of HERA, NeoALTTO, APHINITY and Olympia studies had been published, and one-Co-I in HERA, APHINITY, Olympia studies and two Co-Is in NeoALTTO study from Taiwan are listed as the co-authors.
A. On-going Clinical Protocols:
| Protocol | Date Activated | Taiwan Sites | Taiwan Cases | Global Cases |
|---|---|---|---|---|
| ALEXIMp030 | 2018.7 ~ now | 10 | 65 | 1,981 |
B. Finished Protocols:
| Protocol | Date Activated | Taiwan Sites | Taiwan Cases | Global Cases |
|---|---|---|---|---|
| Olympia | 2014.4 ~ 2019.5 | 11 | 10 | 1,824 |
| PALLAS | 2015.10 ~ 2018.11 | 5 | 31 | 5,552 |
| APHINITY | 2011.11 ~ 2013.8 | 7 | 170 | 4,805 |
| ALTTO | 2007.5 ~ 2011.6 | 8 | 374 | 8,283 |
| NeoALTTO | 2008.1 ~ 2009.11 | 7 | 57 | 450 |
| HERA | 2001.11 ~ 2005.3 | 4 | 100 | 5,099 |
