試験ID UMIN000025659
最終情報更新日：2026年3月30日
切除不能進行・再発大腸癌に対する二次治療としての FOLFIRI+ramucirumab療法の臨床第II相試験
基本情報
| 試験ID | UMIN000025659 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 切除不能進行・再発大腸癌に対する二次治療としての FOLFIRI+ramucirumab療法の臨床第II相試験 | A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer |
| 平易な研究名称 / Public Title（Acronym） | A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer | |
| 試験進捗状況/Recruitment status | 試験終了 | Complete: follow-up complete |
| 登録日時 | 2017年4月1日 | |
| 最終情報更新日 | 2026年3月30日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | Japan |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 60 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 大腸癌 | colorectal cancer |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | FOLFIRI+ラムシルマブ療法 ・ramucirumab (RAM)：8 mg/kgをday1に60分で静脈内投与する． ・l-leucovorin (l-LV)：200 mg/m2をday1に120分で静脈内投与する． ・irinotecan (IRI)： 150 mg/m2をday1に90分で静脈内投与する． ・bolus 5-fluorouracil (5-FU)：400 mg/m2をday1に急速静脈内投与する． ・infusional 5-FU：2400 mg/m2をday1-3にかけて46時間で持続静脈内投与する． | |
| 主要評価項目 / Primary outcomes | 無増悪生存期間 | progression-free survival (PFS) |
| 副次評価項目 / Secondary outcomes | Overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), early tumor shrinkage (ETS), depth of response (DpR), two-dimensional response (2-DR), relative dose intensity (RDI) of irinotecan and ramucirumab, and incidence of adverse events | |
適格性
| 年齢（下限）/ Age minimum | 20歳以上 | 20years-old |
|---|---|---|
| 年齢（上限）/ Age maximum | 80歳未満 | 80years-old |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | 1. Histologically confirmed colorectal adenocarcinoma. 2. Unresectable metastatic disease. 3. Age 20 to 80 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Prior oxaliplatin-based chemotherapy. 6. Prior bevacizumab or anti-EGFR containing regimen. 7. Bidimensionally measurable disease. 8. Adequate organ function. 9. The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization. 10. Written informed consent was obtained. | |
| 除外基準 / Exclude criteria | 1. Previous history of severe drug-induced allergy 2. Brain metastasis 3. Cerebrovascular disease or its symptoms within 1 year. 4. Massive pleural effusion or ascites that required drainage. 5. History of active double cancer. 6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. 7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 8. History of gastrointestinal perforation within 1 year. 9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. 10. Severe renal failure or urinary protein (more than 2+). 11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). 12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated. 13. Interstitial lung disease or pulmonary fibrosis. 14. Uncontrolled infection. 15. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. 16. UGT1A1 gene status of homo type (*28/*28, *6/*6) or double hetero-type genetic polymorphisms *28 or *6 (*1/*28 and *1/*6). 17. Prior irinotecan or ramucirumab containing chemotherapy 18. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 19. Not appropriate for the study at the physician's assessment. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Goro Nakayama | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery | |
| 住所 / Address | 65 Tsurumai-chi, Showa-ku, Nagoya, Japan Japan | |
| 電話 / Telephone | 0527442250 | |
| 実施責任組織 / Affiliation | 名古屋大学大学院医学系研究科消化器外科 | Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery |
| 研究費提供組織 / Funding Source | Eli Lilly Japan K.K. | |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 65 Tsurumai-chi, Showa-ku, Nagoya, Japan Japan | |
|---|---|---|
| 電話 / Telephone | 0527442250 | |
| ホームページURL | ||
| goro@med.nagoya-u.ac.jp | ||
| 担当者 / Name of contact person | Goro Nakayama |