JPRN-jRCTs041220120招募中2 期
Randomized Phase II Trial of Trifluridine/tipiracil (FTD/TPI) plus Ramucirumab (RAM) versus Trifluridine/tipiracil in Previously Treated Patients with Advanced Gastric or Esophagogastric Junction Adenocarcinoma. (WJOG15822G)
Hiroki Hara0 个研究点目标入组 110 人开始时间: 2023年1月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age is 20 years or older.
- •2. Histologically diagnosed as adenocarcinoma (general type) of the gastric or esophagogastric junction.
- •3. HER2 test has been performed before registration (regardless of HER status).
- •4. Unresectable progression or recurrence comfirmed by CT scan.
- •5. ECOG performance status (PS) is 0 or 1.
- •6. Expected to survive for 3 months or more.
- •7. One or more measurable lesions.
- •8. Pretreatment (refractory or intolerant to the following drugs).
- •Fluoropyrimidine, Taxane or Irinotecan (Eligible even if you have used both drugs), Ramucirumab (eligible only for refractory cases)
- •9. Organ and bone marrow functions are maintained.
- •10. Written consent has been obtained.
排除标准
- •1. Have active double cancer (simultaneous double cancer / multiple cancer and metachronous double cancer or multiple cancer with a disease-free period of 2 years or less).
- •2. Oral intake is difficult. Specifically, cases that require daily infusion for nutrition and water intake purposes even after registration.
- •3. Pre-treatment including FTD / TPI in the past.
- •4. Have hypersensitivity of the drugs used in this study.
- •5. Past history of major surgery (general anesthesia required) within 4 weeks before registration and radiation therapy covering the abdomen within 2 weeks. However, examination laparoscopy performed for diagnostic purposes is excluded.
- •6. Cases with severe pleural effusion (when occupying more than half of the thoracic cavity, or when frequent thoracentesis is required).
- •7. Have severe ascites or have a history of palliative ascites puncture (excluding test puncture for examination) within 2 weeks.
- •8. Cases with brain metastasis and tumor metastasis to the central nervous system
- •9. Adverse events (non-hematological toxicity) of poorly controlled Grade 2 or higher (CTCAE v5.0) remain at the time of registration (hair loss, dysgeusia, pigmentation, peripheral neuropathy could be registerd even if Grade 2 or higher)
- •10. Have a local or systemic active infection that requires treatment.
- •11. Despite antihypertensive drug treatment, he has uncontrolled hypertension.
- •12. Complicated with uncontrolled diabetes.
- •13. Unstable angina (angina that develops or is exacerbated by attacks within 4 weeks prior to enrollment), uncontrolled heart failure, arrhythmia requiring treatment (mild right bundle branch block, extrasystoles, etc.) Excluding arrhythmias that are not clinically problematic).
- •14. Have serious hemorrhagic disorders or vasculitis. Cases with significant gastrointestinal bleeding episodes (Grade 3 or higher) within 12 weeks prior to enrollment.
- •15. Have a history of gastrointestinal perforation or fistula within 24 weeks prior to registration.
- •16. Have a history of gastrointestinal obstruction or inflammatory bowel disease such as Crohn's disease. However, regarding gastrointestinal obstruction, cases in which colostomy or bypass surgery has been performed in the past and oral intake is sufficiently possible are excluded.
- •17. Have a history of unrecovered trauma, active gastric ulcer, or fracture within 4 weeks prior to enrollment.
- •18. Have a history of arterial thrombosis (including myocardial infarction and cerebral infarction) within 24 weeks before registration.
- •19. there is a history of deep vein thrombosis or pulmonary artery thrombosis (excluding catheter thrombosis and superficial thrombosis) within 12 weeks before registration.
- •20. Immune deficiency (such as HIV infection), autoimmune diseases with administration of systemic steroids.
- •21. Received antiplatelet drugs (clopidogrel, ticlopidine, dipyridamole, etc.). Low doses of aspirin (less than 325 mg / day) and non-steroidal anti-inflammatory drugs (NSAIDs) can be enrolled. If anticoagulant is administered for thrombosis that can be confirmed on the image, it is excluded. Anticoagulant therapy for the prevention of thrombosis with stable coagulation function (PT-INR less than facility standard upper limit x 1.5) for 12 weeks or more before registration, it is eligible.
- •22. There is continuous use of systemic steroids (excluding contrast agent allergy prophylaxis, pre-medication of anti-cancer agents, hydrocortisone replacement therapy for adrenal hypofunction o
研究者
相似试验
招募中
2 期
Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5- fluorouracile ± nivolumab in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer2024-512999-35-00Unicancer118
尚未招募
2 期
Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer.colorectal cancerNL-OMON56792niversitair Medisch Centrum Utrecht40
已完成
2 期
A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapyER-positive breast cancerHer2 negative10006291Metastatic breast cancerNL-OMON52884BOOG Study Center50
进行中（未招募）
2 期
TAS102 in patients with ER-positive, HER2-negative advanced breast cancer (TIBET study)Advanced breast cancer2024-519204-27-00BOOG Study Center B.V.50
撤回
2 期
A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast CancerMetastatic Triple Negative Breast CancerNCT04149444AHS Cancer Control Alberta