Cancer Clinical Trials

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
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