JPRN-jRCTs061180002进行中（未招募）2 期
A phase II study of second-line combination therapy with FOLFIRI plus ramucirumab in patients with RAS wild-type unresectable advanced/recurrent colorectal cancer (JACCRO CC-16) - JACCRO CC-16
TSUJI Akihito0 个研究点目标入组 90 人开始时间: 2018年12月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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)Patients with histologically confirmed colorectal cancer
- •(2)Patients with RAS wild-type (KRAS exon 2 [codon12,13], exon 3 [codon59,61], exon 4 [codon117,146]; NRAS exon 2 [codon12,13], exon 3 [codon59, 61], exon 4 [codon117,146]), unresectable advanced/recurrent colorectal cancer
- •(3)Patients aged >= 20 years at the time of informed consent
- •(4)Patients with ECOG Performance Status (PS) 0 to 1
- •(5)Patients who have received any of 1) to 3) for the treatment of unresectable primary lesion site and unresectable distant metastasis or lymph node metastasis
- •1)Patients who have received 5-FU plus oxaliplatin plus an anti-EGFR antibody as a first-line therapy and have become refractory or intolerant to the therapy
- •2)Patients in whom the regimen needs to be changed because early tumor shrinkage (ETS) by >= 20% has not been obtained at efficacy assessment at Week 8 after the start of a first-line therapy with 5-FU plus oxaliplatin plus an anti-EGFR antibody
- •3)Patients who have received a combination with FOLFOXIRI plus an anti-EGFR antibody drug as a first-line therapy and have become refractory or intolerant during the subsequent maintenance therapy (with 5-FU plus levofolinate plus an anti-EGFR antibody drug)
排除标准
- •(1)Patients with synchronous multiple primary cancers or with metachronous multiple primary cancers with disease interval of <= 5 years
- •(2)Patients with brain metastasis
- •(3)Patients with infection
- •(4)Patients with interstitial pneumonia or pulmonary fibrosis
- •(5)Patients with a serious cardiac disease or patients with a history of a serious cardiac disease within 12 months before enrollment
- •(6)Patients with any of the following previous or concomitant diseases associated with hemorrhage:
- •1)Intractable hemorrhage
- •2)Active hematemesis/hemoptysis
- •3)Gastrointestinal hemorrhage of >= Grade 3 within 3 months before enrollment
- •(7)Patients with any of the following previous or concomitant diseases associated with thromboembolism
- •1)Intractable thromboembolism
- •2)Any thrombosis, including deep vein thrombosis and pulmonary embolism, within 3 months before enrollment
- •(8)Patients with any cerebrovascular disorder
- •(9)Patients with poorly controlled hypertension
- •(10)Patients with cancerous body cavity fluid (such as pleural effusion, ascites, and cardiac effusion) requiring puncture and/or administration of diuretics
- •(11)Patients with any serious concurrent disease (such as renal failure and hepatic failure)
- •(12)Male patients with no will to take contraceptive measures, pregnant patients, breastfeeding patients, female patients with a positive result on pregnancy test, or female patients with no will to take contraceptive measures
- •(13)Patients with a past history of severe hypersensitivity
- •(14)Patients with a positive result for HBs antigen or HCV antigen
- •(15)Patients with hepatic cirrhosis of Child-Pugh class B or severer, or patients with hepatic encephalopathy regardless of the degree of the hepatic cirrhosis
- •(16)Patients who have received blood transfusion, blood products, or hematopoietic factor preparations such as G-CSF within 7 days before enrollment
- •(17)Patients who have received surgery, biopsy with incision, or suture for injury within 28 days before enrollment, or patients who have received central venous port placement or minor surgery within 7 days before enrollment
- •(18)Patients who need to be treated or are under treatment with drugs that inhibit platelet function (aspirin of >= 325 mg once daily or non-steroidal anti-inflammatory drugs [NSAIDs]) for the treatment of chronic inflammatory diseases such as rheumatoid arthritis
- •(19)Patients receiving antiplatelet therapy with drugs, including aspirin, dipyridamole, clopidogrel, and NSAIDs (excluding aspirin of <= 325 mg once daily)
- •(20)Patients with bleeding tendency (including hemoptysis, and hollowing or necrosis of lung metastasis on images), coagulation disorder, or abnormal coagulation factor
- •(21)Patients with active peptic ulcer
- •(22)Patients with gastrointestinal perforation or fistula, or patients with a history of gastrointestinal perforation or fistula within 6 months before enrollment
- •(23)Patients with unhealed traumatic fracture
- •(24)Patients with watery stools or uncontrolled diarrhea
- •(25)Patients with a history of organ transplantation requiring immunosuppressants
- •(26)Patients who have previously received ramucirumab
- •(27)Patients receiving atazanavir sulfate (Rayataz)
- •(28)Patients with intestinal paralysis or intestinal obstruction
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