癌症試驗

1. 多中心癌症臨床試驗

TCOG針對國內主要癌症推動執行跨院際之癌症臨床試驗,以期快速找出適合國人之癌症治療方法,提昇癌症治療水準。TCOG邀集全國各大醫院有興趣之相關科別醫師參與合作癌症研究計畫,執行個案篩檢、收案、計畫治療及追蹤存活狀態。目前已完成T1188乳癌、T1488淋巴癌、T1788軟組織肉瘤、T1592小細胞肺癌、T1394晚期鼻咽癌、T1495淋巴癌、T1296胃淋巴癌、胃腺癌病患表格登錄、T1297肝癌術後、T1899子宮頸抹片篩檢、T2201胃癌、T1E01子宮頸癌、T3202膽道癌、T1802攝護腺癌、T2399口腔癌、T1401淋巴癌、大腸直腸癌病患表格登錄、T1399口腔癌、T2202肝癌、T1202大腸直腸癌、T1204胰臟癌、T1303鼻咽癌、T1405 淋巴癌、T1406淋巴瘤、T1706軟組織惡性肉瘤、T1209肝癌、T1206肝癌、T2207大腸癌、T1309口腔癌、T1210膽臟癌、T1306口腔癌、T2209胰臟癌、T3211胃癌、T2211胃腸道基質瘤、T3207胰臟癌、T3206胃淋巴瘤、T1211胰臟癌、T1408淋巴癌、TG1308膽道癌、T1313鼻咽癌、T2312鼻咽癌、T3214膽道癌、T3212胰臟癌、T1Z14神經內分泌瘤、T2212胰臟癌、T1914白血病、等四十六個研究計畫,總計收錄8,161例個案,已發表24篇研究論文。執行中之計畫計有T1214胃腸道基質瘤暨神經內分泌腫瘤、T2214胃淋巴瘤、T1216消化道癌、T5217胰臟癌、T3217膽道癌、T1217胰臟癌、T1218胃腸道基質瘤、T2317頭頸癌、T2217肝癌、T1317鼻咽癌等十個研究計畫,至2019年7月底總計收案1053例,尚有1254例個案執行計畫治療中。2019年下半年尚有TG1709膽道癌、T6217肝癌、T1219膽道癌、T1519肺癌、T1419淋巴瘤數個新計畫將開始送審執行。
執行中研究計畫 (更新至 Jul. 2019)
代號 計畫書 主持人 計畫執行期 預期收案數 實際收案數
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
已結束之研究計畫
代號 計畫書 主持人 計畫執行期 實際收案數
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. 國際合作癌症臨床試驗

TCOG於2006年加入為國際乳癌組織 (Breast International Group, BIG) 會員,並參與其所推動之跨國際乳癌臨床試驗。歷年來TCOG代表台灣參與完成HERA、NeoA、LTTO、ALTTO、APHINITY、PALLAS、Olympia等六個乳癌國際研究計畫,總計全球收錄26,013例個案,其中台灣收錄742例。進行中之ALEXIMp030計畫台灣共計10家醫院參與,已篩選8例,進案5例;全球總進案237例。

HERA、NeoALTTO、APHINITY計畫之研究成果已經發表。其中HERA計畫台灣有一位醫師列名共同作者;ANeoALTTO計畫台灣是23個地區收案最多的國家、委員亦為收案最多的醫師之一,計畫之主要論文已於2011年12月被Lancet Oncology接受發表,台灣並有二位醫師列名共同作者;APHINITY計畫亞太區收案情形台灣排名第三,試驗單位部分北榮收案排名第五、台大第六位、中榮並列第十位。

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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