Drugs / S-1
last change 10 days ago re-read 8 days ago

S-1

Small molecule

Developed for
gastric cancer · malignant pancreatic neoplasm · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · biliary tract cancer · colorectal cancer · esophageal squamous cell carcinoma · gastric neoplasm
+51 more · esophageal cancer · non-small cell lung carcinoma · gastroesophageal adenocarcinoma · pancreatic neoplasm · peritoneal carcinomatosis · cholangiocarcinoma · nasopharyngeal carcinoma · colorectal neoplasm · gastric carcinoma · pancreatic ductal adenocarcinoma · hepatocellular carcinoma · gastroesophageal cancer · pancreatic adenocarcinoma · pancreatic exocrine neoplasm · adenocarcinoma · biliary tract neoplasm · breast neoplasm · cancer · carcinoma of gallbladder and extrahepatic biliary tract · digestive system neoplasm · head and neck cancer · intrahepatic cholangiocarcinoma · metastatic malignant neoplasm · rectal cancer · rectal carcinoma · small cell lung carcinoma · breast cancer · carcinoma · carcinoma of esophagus · cervical cancer · colon carcinoma · colorectal adenocarcinoma · diffuse gastric cancer · digestive system cancer · Epstein-Barr virus-associated gastric carcinoma · esophageal adenocarcinoma · exocrine pancreatic carcinoma · female breast carcinoma · gastric linitis plastica · head and neck neoplasm · head and neck squamous cell carcinoma · malignant colon neoplasm · malignant exocrine pancreas neoplasm · neoplasm · neoplasm of esophagus · neuroendocrine carcinoma · neuroendocrine neoplasm · periampullary adenocarcinoma · peritoneal neoplasm · small intestine cancer · transitional cell carcinoma
Investigated by
Taiho Pharmaceutical Co., Ltd. · Fudan University · Chinese Academy of Medical Sciences · Sun Yat-sen University · Peking University · The First Affiliated Hospital with Nanjing Medical University
+215 more · Zhejiang Cancer Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chinese PLA General Hospital · Ruijin Hospital · Taiho Oncology, Inc. · Asan Medical Center · Hallym University Medical Center · Beijing Friendship Hospital · Jiangsu HengRui Medicine Co., Ltd. · National Cheng-Kung University Hospital · Tianjin Medical University Cancer Institute and Hospital · National Cancer Center, Korea · Chang Gung Memorial Hospital · Fujian Cancer Hospital · Jeil Pharmaceutical Co., Ltd. · Kansai Hepatobiliary Oncology Group · Hebei Medical University · National Health Research Institutes, Taiwan · National Taiwan University Hospital · Peking Union Medical College Hospital · Quintiles, Inc. · Sanofi · Seoul National University Hospital · TTY Biopharm · China Medical University Hospital · Japan Clinical Cancer Research Organization · Korean Cancer Study Group · Samsung Medical Center · Shanghai Zhongshan Hospital · Taipei Veterans General Hospital, Taiwan · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Yonsei University · Academic Medical Center - University of Amsterdam · Aiping Zhou · AstraZeneca · Chonnam National University Hospital · Gachon University Gil Medical Center · Hebei Medical University Fourth Hospital · Henan Cancer Hospital · Hokkaido Gastrointestinal Cancer Study Group · Peking University Cancer Hospital & Institute · Qilu Hospital of Shandong University · Seoul National University Bundang Hospital · Tang-Du Hospital · United BioSource, LLC · Yu jiren · Zhejiang Provincial People's Hospital · Zhejiang University · AIO-Studien-gGmbH · Anhui Provincial Hospital · CSPC Ouyi Pharmaceutical Co., Ltd. · Changhai Hospital · Eli Lilly and Company · First People's Hospital of Hangzhou · Guangdong Provincial Hospital of Traditional Chinese Medicine · Innovent Biologics (Suzhou) Co. Ltd. · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Jinling Hospital, China · Kaohsiung Veterans General Hospital. · Liaoning Cancer Hospital & Institute · Nordic Pharma SAS · Peking University Third Hospital · Qingdao Central Hospital · Shandong Provincial Hospital · Sichuan University · The First Affiliated Hospital of Zhengzhou University · The First People's Hospital of Changzhou · UMC Utrecht · Xijing Hospital · Yakult Honsha Co., LTD · Yongxu Jia · 307 Hospital of PLA · Affiliated Hospital of Hebei University · Affiliated Hospital of Qinghai University · all 221 on the full record

Trials 344 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07356466 May 2025 → Apr 2027 expected gastric cancer Fujian Medical University Enrolling by invitation No outcome recorded
Phase 122 trials
Phase 1 NCT06229496 Aug 2023 → Dec 2027 expected pancreatic adenocarcinoma Chang Gung Memorial Hospital Recruiting No outcome recorded
Phase 1 NCT03977220 Jan 2020 → Dec 2021 gastric cancer Shanghai Zhongshan Hospital Unknown No outcome recorded
Phase 1 NCT03380689 Jan → Jul 2018 colorectal cancer Fujian Cancer Hospital Withdrawn No outcome recorded Stop: Business
Phase 1 NCT03276156 Feb 2016 → Feb 2018 gastric cancer Zhejiang Cancer Hospital Unknown No outcome recorded
Phase 1 NCT02359058 Feb 2015 → Jul 2016 gastric neoplasm Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02347904 Dec 2014 → Nov 2019 esophageal cancer Academic Medical Center - University of Amsterdam Completed No outcome recorded
Phase 1 NCT02277158 Nov 2014 → Jun 2015 rectal cancer Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Unknown No outcome recorded
Phase 1 NCT02387138 Apr 2014 → Jun 2018 digestive system cancer Institut du Cancer de Montpellier - Val d'Aurelle Completed No outcome recorded
Phase 1 NCT01946646 Oct 2013 → Jan 2017 malignant pancreatic neoplasm National Taiwan University Hospital Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01610479 Jun 2012 → Feb 2017 cancer Taiho Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1/225 trials
Phase 1/2 NCT06732856 Apr 2025 → Dec 2027 expected gastric cancer Asan Medical Center Recruiting No outcome recorded
Phase 1/2 NCT06266871 Mar 2024 → Jun 2026 overdue gastric cancer West China Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT06038461 Sep 2023 → Sep 2026 overdue neuroendocrine neoplasm Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 1/2 NCT05403242 Sep 2022 → Sep 2025 overdue gastroesophageal adenocarcinoma Chinese PLA General Hospital Recruiting No outcome recorded
Phase 1/2 NCT05322577 May 2022 → Nov 2025 overdue gastric cancer, gastroesophageal junction adenocarcinoma Amgen Active not recruiting No outcome recorded
Phase 1/2 NCT05218889 Aug 2021 → Dec 2024 overdue pancreatic ductal adenocarcinoma Chinese PLA General Hospital Recruiting No outcome recorded
Phase 1/2 NCT04662112 Jun 2021 → Oct 2023 pancreatic ductal adenocarcinoma Asan Medical Center Completed No outcome recorded
Phase 1/2 NCT04781413 Mar 2021 → Mar 2024 gastric carcinoma Ruijin Hospital Unknown No outcome recorded
Phase 1/2 NCT03991104 May 2019 → Dec 2021 esophageal cancer Zhejiang Provincial People's Hospital Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT03654612 Oct 2018 → Mar 2020 head and neck cancer China International Medical Foundation Unknown No outcome recorded
Phase 2237 trials · 2 met primary · 5 missed
Phase 2 NCT07847710 Sep 2026 → Mar 2028 expected intrahepatic cholangiocarcinoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2 NCT07602140 Aug 2026 → Aug 2028 expected gastric cancer Shandong Provincial Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07621484 Jul 2026 → May 2028 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Shanghai Changzheng Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07685704 Jul 2026 → Jun 2028 expected gastric cancer, gastroesophageal junction adenocarcinoma Zhifeng Zhao, PhD Not yet recruiting No outcome recorded
Phase 2 NCT07636824 Jun 2026 → Feb 2029 expected carcinoma of gallbladder and extrahepatic biliary tract Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT07776639 May 2026 → Sep 2027 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Yongxu Jia Active not recruiting No outcome recorded
Phase 2 NCT07000253 Apr 2026 → Nov 2031 expected carcinoma of esophagus, gastric adenocarcinoma Academic Medical Center - University of Amsterdam Recruiting No outcome recorded
Phase 2 NCT07561775 Apr 2026 → Jan 2028 expected cholangiocarcinoma Xingjun Guo Not yet recruiting No outcome recorded
Phase 2 NCT07515625 Apr 2026 → Apr 2028 expected gastric cancer, gastroesophageal adenocarcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07507916 Apr 2026 → Dec 2029 expected gastric cancer, gastroesophageal junction adenocarcinoma Fudan University Not yet recruiting No outcome recorded
Show all 237 trials opens the full record — a long page
Phase 2/38 trials · 2 met primary · 1 missed
Phase 2/3 NCT03691454 Jun 2018 → Sep 2026 overdue gastric adenocarcinoma Peking University Active not recruiting No outcome recorded
Phase 2/3 NCT02979691 Oct 2016 → Apr 2020 esophageal squamous cell carcinoma, gastroesophageal cancer Chinese Academy of Medical Sciences Completed Met primary
Phase 2/3 NCT02193594 Jan 2014 → Sep 2017 gastroesophageal junction adenocarcinoma Peking University Unknown No outcome recorded
Phase 2/3 NCT01704690 Aug 2012 → Mar 2017 esophageal cancer Peking University Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT01516944 Feb 2012 → Apr 2018 gastric cancer Hebei Medical University Completed Met primary
Phase 2/3 NCT02442362 Jan 2012 → Jan 2014 gastric cancer The First People's Hospital of Changzhou Completed No outcome recorded
Phase 2/3 NCT00639327 Mar 2008 → Apr 2011 gastric cancer Japan Clinical Cancer Research Organization Completed Missed primary
Phase 2/3 NCT00503321 Oct 2006 → Aug 2009 gastric cancer Eastern Network of Cancer Immunological Therapy, Japan Terminated No outcome recorded Stop: Enrollment
Phase 335 trials · 9 met primary · 4 missed
Phase 3 NCT07689539 Sep 2026 → Jul 2028 expected malignant pancreatic neoplasm Jiangxi Kvvit Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07366528 Dec 2025 → Oct 2028 expected gastric cancer Ruijin Hospital Recruiting No outcome recorded
Phase 3 NCT06571461 Sep 2024 → Jan 2028 expected malignant pancreatic neoplasm CSPC Ouyi Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT05771480 Aug 2023 → Oct 2025 overdue biliary tract cancer AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT04483076 Jan 2021 → Dec 2022 overdue gastric cancer Chinese PLA General Hospital Recruiting No outcome recorded
Phase 3 NCT03941561 Jan 2019 → Jan 2022 overdue gastric cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT03708536 Nov 2018 → Nov 2021 colorectal adenocarcinoma Fujian Cancer Hospital Withdrawn No outcome recorded Stop: Business
Phase 3 NCT03700333 Oct 2018 → Oct 2019 non-small cell lung carcinoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
Phase 3 NCT03680261 Oct 2018 → Sep 2023 gastric cancer Shanghai Zhongshan Hospital Unknown No outcome recorded
Phase 3 NCT02813967 Jun 2016 → Aug 2020 esophageal squamous cell carcinoma Zhejiang Cancer Hospital Completed Met primary
Phase 44 trials
Phase 4 NCT06779318 Jul 2025 → Jul 2027 expected malignant pancreatic neoplasm The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 4 NCT04217096 Jan 2020 → Sep 2022 pancreatic neoplasm Fudan University Unknown No outcome recorded
Phase 4 NCT01997957 Oct 2013 → Sep 2016 hepatocellular carcinoma Zhu Xu Unknown No outcome recorded
Phase 4 NCT01849380 Jun → Oct 2013 breast cancer Shandong University Unknown No outcome recorded
Phase not applicable12 trials · 1 met primary
— NCT07855757 Jun 2026 → Jun 2028 expected gastric cancer, peritoneal carcinomatosis Zhejiang Cancer Hospital Active not recruiting No outcome recorded
— NCT06966440 Jun 2025 → Jun 2028 expected pancreatic adenocarcinoma Ruijin Hospital Recruiting No outcome recorded
— NCT06171321 Dec 2023 → Nov 2025 biliary tract cancer Shanghai East Hospital Unknown No outcome recorded
— NCT04889768 Jul 2021 → Jul 2023 — Zhejiang Cancer Hospital Unknown No outcome recorded
— NCT04886193 Apr 2021 → May 2022 gastric cancer Guangdong Provincial Hospital of Traditional Chinese Medicine Unknown No outcome recorded
— NCT04274270 Apr 2020 → Jan 2022 — Peking University Third Hospital Unknown No outcome recorded
— NCT05028439 Jan 2020 → Dec 2022 cholangiocarcinoma First People's Hospital of Hangzhou Completed No outcome recorded
— NCT04047953 Sep 2019 → Dec 2023 overdue gastric adenocarcinoma Peking University Cancer Hospital & Institute Recruiting No outcome recorded
— NCT03413514 Jan 2018 → Jan 2019 gastric cancer Peking University Unknown No outcome recorded
— NCT02592538 Dec 2015 → Aug 2018 cholangiocarcinoma First People's Hospital of Hangzhou Completed No outcome recorded
Comparator or background therapy111 trials
Phase 1 NCT05867121 Background Oct 2023 → Mar 2026 gastric cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma Genentech, Inc. Completed No outcome recorded
Phase 1 NCT03162510 Background Jun 2018 → Jun 2021 biliary tract cancer, malignant pancreatic neoplasm, stomach carcinoma in situ National Health Research Institutes, Taiwan Completed No outcome recorded
Phase 1 NCT02862535 Background Sep 2016 → Oct 2019 gastric adenocarcinoma Gilead Sciences Terminated No outcome recorded
Phase 1 NCT00553696 Background Nov 2007 → Jul 2009 gastric neoplasm Pfizer Completed No outcome recorded
Phase 1 NCT00479076 Background Mar 2007 → Jan 2011 neoplasm Sanofi Completed No outcome recorded
Show all 111 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2025-04-10 InnoPharmax Inc. Results Completion of Stage 1 in the Phase II/III Clinical Trial of D07001 Softgel Capsules for Advanced Biliary Tract Cancer. innopharmax.com ↗
Data indicate that D07001 softgel capsules, at the maximum tolerated dose (MTD), can be safely combined with Xeloda or TS-1, supporting dose selection for subsequent studies.
2016-12-13 TTY Biopharm Regulatory 台灣東洋藥品公司之癌症口服化療藥物獲胃癌術後輔助性治療之健保給付 [財經版] com.tw ↗
這是此癌症口服化療藥物繼2014年6月取得『局部晚期無法手術切除或轉移性胰臟癌病人』給付後,第二個獲健保給付的適應症。
2014-06-01 TTY Biopharm Regulatory 台灣東洋癌症用藥TS-1(愛斯萬® )獲晚期胰臟癌之健保給付 com.tw ↗
現台灣通過晚期胰臟癌健保給付,將提供病人一個有效且方便性高的新治療選擇,每年可嘉惠約1,500位晚期胰臟癌患者。
2007-07-23 Jeil Pharmaceutical Co., Ltd. Results 항암제 "TS-1" 위암 사망 32% 감소 jeilpharm.co.kr ↗
그 결과, TS-1 투여그룹의 사망위험은 비투여 그룹에 비해 32% 감소했으며, 3년 후 생존율은 비투여 그룹이 70.1%, 투여그룹이 80.5%를 나타냈다.
2007-07-23 Jeil Pharmaceutical Co., Ltd. Results TS-1에 시스플라틴 병용 생존기간 연장 jeilpharm.co.kr ↗
그 결과, 병용그룹은 단독그룹에 비해 사망위험이 22.6% 유의하게 감소한 것으로 나타났다.
2002-10-28 Jeil Pharmaceutical Co., Ltd. Results 경구용 항암제 TS-1 심포지엄 jeilpharm.co.kr ↗
또한, TS-1과 Cisplatin 병용요법 2상 결과에서 76%의 경이적인 유효율을 나타냈다는 점에 놀라움을 표시하며, 본 약제가 보다 빨리 국내에 도입되어 많은 암환자에게 새로운 희망을 줄 수 있기를 기대했다.

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 457 sources stand behind the page.

FieldValueCited text
Known as S-1 “Patients will be administered with appropriate adjuvant chemotherapy regimens including but are not limited to: GEM monotherapy/adjustable GEM monotherapy, S-1...” NCT06966440 ↗
458

“S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an...” NCT04267549 ↗

“In this open-label, single-arm, phase 2 trial, in each 21-day cycle, eligible patients received 200 mg intravenous camrelizumab in the first day, 500 mg oral apatinib once...” PMID 35304622 ↗ Mar 2022

“SOX: S-1 twice a day, days 1-14, the dose of S-1 is accorded to body-surface area (BSA): patients with a BSA of less than 1.25 m2 receive 80 mg daily; those with a BSA of 1.25...” NCT06121700 ↗

“Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or...” NCT01781520 ↗

“Adjuvant chemoradiotherapy (1 cycle CT: Oxaliplatin plus capecitabine (Xelox) or S-1 plus oxaliplatin (SOX), Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine...” NCT03680261 ↗

“A phase III randomized, multicenter, trial comparing adjuvant (arm A) or perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin...” PMID 32583567 ↗ Jun 2020

“Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid...” NCT02870153 ↗

“SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid,...” NCT02356276 ↗

“Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130...” NCT05975749 ↗

“S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks...” NCT03961867 ↗

Show 448 more sources

Known as 452500ACH “S-1 (452500ACH)” NCT02191566 ↗
Known as S-1 (TS-1, Taiho, JP) “S-1 (TS-1, Taiho, JP)” NCT04999332 ↗
Known as S-1; TS-1 “S-1; TS-1” NCT01096745 ↗
Known as S1: Gimeracil and oteracil porassium capsules “S1: Gimeracil and oteracil porassium capsules” NCT02223611 ↗
Known as Tegafur Gimeracil Oteracil Potassium “S-1 (tegafur-gimeracil-oteracil potassium) combined with radiotherapy in these subsets of ESCC patients” PMID 35449578 ↗ Apr 2022
2

“Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)” NCT00503321 ↗

“Tegafur Gimeracil Oteracil Potassium Capsules (S-1)” NCT07304258 ↗

Known as Tegafur, Gimeracil and Oteracil Porassium Capsules “Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)” NCT03475615 ↗
Known as Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) “A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.” NCT02277158 ↗
Known as Tegafur/Gimeracil/Oteracil “The SOX regimen consisted of three cycles of oxaliplatin 130 mg/m2 intravenous on day 1 and oral Tegafur/Gimeracil/Oteracil (S-1) 80 mg/m2 twice daily on days 1-14, repeated...” PMID 41181842 ↗ Oct 2025
Known as Teysuno “Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。” NCT06171321 ↗
Known as Tiggio capsule “Tiggio capsule (S-1) 40-60mg (BSA\<1.25 m2: 40mg, 1.25 m2≤BSA≤1.5 m2: 50mg, BSA\> 1.5 m2: 60mg) po bid d1-14 Q3W, continuous treatment for 1 year;” NCT04886193 ↗
Known as Tiggio Capsules “Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w” NCT05193292 ↗
Known as Tigio “Tigio (S-1), 40-60 mg orally twice daily on days 1 to 14.” NCT06576921 ↗
Known as Tigio Capsules “Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14.” NCT04792515 ↗
Known as TS-1 “Tegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan” NCT00503321 ↗
4

“Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas.” PMID 19052037 ↗ Dec 2008

“S-1 (TS-1) and Oxaliplatin (Oxalitin)” NCT00961077 ↗

“Gemcitabine;gemzer , S-1;TS-1” NCT01713387 ↗

“TS-1 (S-1)” NCT00152217 ↗

Action Inhibit “inhibit dihydropyrimidine dehydrogenase (DPD)” NCT00072787 ↗
Modality Small molecule “S-1 is an oral fluoropyrimidine” NCT00072787 ↗
Route Oral “S-1 is an oral fluoropyrimidine” NCT00072787 ↗