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由研究人員發起之跨院際學術性臨床試驗，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、T5217胰臟癌、T2214胃淋巴瘤、T1217胰臟癌、T1214胃腸道基質瘤暨神經內分泌腫瘤、T2317頭頸癌、T1317鼻咽癌、T3217膽道癌、T1216消化道癌、T1219膽道癌、TG1709胰臟癌、T2217肝癌、T1519肺癌等五十八個研究計畫之個案收錄，總計收錄9,287例個案，已發表34篇研究論文。目前持續執行收案中之計畫計有T2219肝癌、T1420淋巴癌、T2420淋巴癌、T1220食道癌、T2221胃腸胰神經內分泌腫瘤、T5221胰臟癌、T2220胃食道癌、T1421淋巴癌、T1222膽道癌、T2222胃腸胰神經內分泌癌等治療型，以及T1218胃腸道基質瘤、T6221胃腸道基質瘤、T1521肺癌、T1221胃腸道基質瘤、T3221膽道癌、T4221食道癌、T2322甲狀腺癌、T1322口咽癌、T4222肝癌、T3322腦癌、T1622黑色素瘤、T1822泌尿道癌等NGS登錄型，共計22個研究計畫，至2023年2月總計收案2,573例；含已結束的計畫尚有2,403例個案執行計畫治療中、持續追蹤168例個案存活狀況。2023年尚有T3222膽道癌、T1223胃癌等數個新計畫將開始送審執行。

TCOG歷年計畫癌別

參與癌症臨床試驗：

癌症藥物及治療方式日新月異，需通過嚴謹的各期臨床試驗後方得以證實其療效。癌症病患必須符合臨床試驗的篩選條件，方能加入該試驗參與計畫治療；由於病患之身體與疾病狀況可能有相當之差異，有意願參與癌症臨床試驗的病患應與您的主治醫師討論洽詢，選擇最符合病患利益之治療方式。

執行中研究計畫 (更新至Feb. 2023)

代號	計畫書	主持人	計畫執行期	預期收案數	實際收案數
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	951
T2219	Atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma (HCC) and chronic hepatitis B virus (HBV) infection	Yung-Yeh Su, Chiun Hsu	2020.03 ~ now	48	35
T2420	A Phase Ib Study of combining Rituximab, Acalabrutinib, and Durvalumab (RAD) in PCNSL.	Shang-Ju Wu, Kwang-Yu Chang	2021.02 ~ now	16-22	13
T1521	The Registry of Genetic Alterations of Taiwan Non-small Cell Lung Cancer	Chih-Hsin Yang, Nai-Jung Chiang	2021.06 ~ now	550	507
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	18
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	45
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	19
T3221	The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer	Ming-Huang Chen, Nai-Jung Chiang	2021.10 ~ now	400	220
T4221	The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan	Chih-Hung Hsu, Shang-Hung Chen	2021.10 ~ now	400	243
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	50
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	4
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	3
T1222	Phase II Trial of Lenvatinib plus Paclitaxel for Patients with Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment	Li -Yuan Bai, Nai-Jung Chiang	2022.7 ~ now	52-55	6
T2222	A phase I/II study of nal-IRI (ONIVYDE®) and carboplatin in patients with advanced or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinom	Ming-Huang Chen, Nai-Jung Chiang	2022.7 ~ now	52-61	6
T2322	A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients	Hui-Jen Tsai, Li-Tzong Chen	2022.8 ~ now	300	100
T1322	The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan	Pei-Jen Lou, Shang-Hung Chen	2022.11 ~ now	300	63
T4222	Dissection of the molecular and immunological interaction in patients with hepatocellular carcinoma of viral and non-viral etiologies	Yung-Yeh Su, Chiun Hsu	2022.11 ~ now	600	192
T1622	The Registry Study of Genetic Alterations of Melanoma in Taiwan	Chiao-En Wu, Nai-Jung Chiang	2022.12 ~ now	250	9
T3322	A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma	Yong-Kwang Tu, Kwang-Yu Chang	2022.12 ~ now	275	20
T1822	The Registry of Genetic Expression of Taiwan Urologic Cancer	Tai-Lung Cha, Kwang-Yu Chang	2023.1 ~ now	500	68

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	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 ~ 20022.4	47
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 ~ 2022.12	50

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13家醫院參與，已進案70例；全球總進案2,199例。

BIG計畫歷年來已發表HERA、NeoALTTO、APHINITY、Olympia計畫共計8篇研究成果期刊論文。其中HERA計畫分別於2005年N Engl J Med期刊和2010年J Clin Oncol期刊、APHINITY計畫於2017年N Engl J Med期刊和2021年J Clin Oncol期刊和2023年ESMO Open期刊、Olympia計畫於2021年N Engl J Med期刊和2022年Ann Oncol期刊中台灣各有一位醫師列名共同作者；NeoALTTO計畫於2012年Lancet期刊中台灣有二位醫師列名共同作者。NeoALTTO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；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	70	2,199

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