JPRN-jRCTs011180029已完成2 期
Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer - HGCSG1603 study
Komatsu Yoshito0 个研究点目标入组 35 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
Although the primary endpoint was not achieved statistically, combination therapy of ramucirumab plus irinotecan showed anticancer activity and a manageable safety profile.
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. Confirmed stage IV or recurrent gastric adenocarcinoma that is refractory or intolerant to initial chemotherapy.
- •2. Age of 20 years or older.
- •3. ECOG PS scale 0-1.
- •4. No history of treatment with irinotecan.
- •5. Confirmation of the progression or recurrence following initial treatment and potential presence of an evaluable lesion less than 28 days before registration using CT or MRI findings, according to RECIST version 1.1. Presence or absence of a measurable lesion is not an inclusion criterion.
- •6. Last day of initial chemotherapy administration is more than 14 days before registration.
- •7. Fulfillment of the standards related to major organ functions within 14 days before registration.
- •8. Patients who are negative for HER-2/neu and those with unknown HER-2/neu status are eligible. HER-2/neu-positive patients are eligible if they received treatments including trastuzumab and if the disease progress is confirmed.
- •9. Available written informed consent.
- •10. Have an estimated life expectancy of >12 weeks in the judgment of the investigator.
- •11. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 12 weeks after the treatment period.
排除标准
- •1. Major surgery within 28 days before registration.
- •2. The patient has a history of DVT, PE, or any other significant thromboembolism during the 3 months prior.
- •3. Administration of anticoagulant therapy such as warfarin and LMWH.
- •4. The patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents.
- •5. Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
- •6. Diagnosis of arterial hypertension that cannot be controlled with standard medical management.
- •7. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.
- •8. Primary cancers diagnosed within the previous five years.
- •9. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia.
- •10. The patient has experienced any arterial thrombotic event within 6 months prior.
- •11. Serious complications or comorbidities.
- •12. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy.
- •13. History of gastrointestinal perforation and/or fistulae within 6 months prior to registration.
- •14. Pericardial or pleural effusion or ascites requiring treatment including drainage.
- •15. Pregnancy, breast-feeding, or plans of pregnancy.
- •16. Local or systemic active infection requiring treatment; however, HBs-Ag positive patients controlled by nucleic acid analogs and those confirmed as HBV DNA can be enrolled.
- •17. Current or recent treatment with another investigational drug or participation in another interventional clinical trial.
- •18. Have known allergy or hypersensitivity to any components of study treatment.
- •19. The patient has: cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
- •20. Participation in the clinical trial is determined as unsuitable.
研究者
相似试验
进行中（未招募）
2 期
A phase II trial of ramucirumab plus irinotecan for patients with early relapced gastric cancerGastric cancer, early relapse, irinotecan, ramucirumabD013274Gastric cancerJPRN-jRCTs051190071YAMAGUCHI Toshifumi40
已完成
1 期
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ CancerGastroesophageal Junction Region (GEJ) CancerGastric CancerNCT02999295National Cancer Center, Japan46
已完成
不适用
Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancerchemo-refractory gastric cancerJPRN-UMIN000019075Osaka University6
已完成
2 期
Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction AdenocarcinomaGastric AdenocarcinomaGastro-esophageal Junction AdenocarcinomaNCT03141034Washington University School of Medicine40
已完成
不适用
Phase I study of Ramucirumab and Irinotecan for metastatic gastric cancer previously treated with Fluoropyrimidine with/without Platinum and Taxane.gastric cancerJPRN-UMIN000018606Kobe City Medical Center General Hospital18