Cancer Clinical Trials

1. Multi-Center Clinical Trials

TCOG has completed 46 trials (1 Breast Cancer, 6 Lymphoma, 2 Soft Tissue Sarcoma, 1 Lung Cancer, 4 Nasopharyngeal Carcinoma, 2 MALToma, 4 Hepatocellular Carcinoma, 3 Gastric Cancer, 2 Cervical Cancer, 4 Biliary Tract Cancer, 1 Prostate Cancer, 4 Oral Cavity Cancer, 3 Colorectal Cancer, 6 Pancreatic Cancer, 1 GIST, 1 NET, 1 CLL, ) with total 8,161 enrolled cases throughout the pass years.  In 2019, there are currently 10 active trials (2 Pancreatic Cancer, 1 P-NET, 1 DLBCL, 1 gastrointestinal tract Cancer), 1 Biliary Tract Cancer, 1 GIST, 1 H&N Cancer, 1 Hepatocellular Carcinoma, 1 Nasopharyngeal Carcinoma) with total 1,053 enrolled cases,  1254 cases are still on-going treatment. Several new protocols will be opened and reviewed in near future. These clinical studies are listed as follows:
On-Going Clinical Trials (update: Jul. 2019)
No. Protocol PI Date Activated Expected Cases Entered Cases
T1214 Multi-center Registration Study for Gastroentero- Pancreatic NET in Taiwan Li-Tzong Chen,
Yen-Shen Shen,
Hui-Jen Tsai
2014.1 ~ now 600 555
T2214 First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL. Sung-Hsin Kuo,
Li-Tzong Chen
2015.4 ~ now 30 13
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, pPancreatic and Biliary Cancers Li-Tzong Chen 2018.2 ~ now 18 10
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 ~ now 130 105
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 ~ now 92 51
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 ~ now 88 26
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 257
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 ~ now 52 30
T2217 Nivolumab plus ipilimumab as neoadjuvant therapy for hepatocellular carcinoma (HCC) Chiun Hsu 2019.1 ~ now  40 4
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 ~ now 63 2
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 1404
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 30
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 ~ 2019.1 256

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 and APHINITY studies had been published, and one-Co-I in HERA study 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 5 237

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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