JPRN-jRCTs031230018招募中2 期
A single-center, phase 2 study to evaluate safety and efficacy of neoadjuvant treatment of Nivolumab for MSI-H/dMMR locally advanced colorectal cancer
Watanabe Jun0 个研究点目标入组 30 人开始时间: 2023年4月11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
- 30
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.The content of this study was fully explained, and written informed consent was obtained from the subject.
- •2.Histologically confirmed colorectal adenocarcinoma.
- •3.Radical resection is clinically possible without any distant metastases in imaging.
- •4.Patients with MSI-H or dMMR.
- •5.At least 18 years of age on the date of consent.
- •6.ECOG Performance Status is 0-1
- •7.No prior treatment for the tumor.
- •8.Cases with cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition
- •9.Patients whose functions of the main organs are adequately maintained.
排除标准
- •1.Extensive surgery (excluding colostomy and central venous porting) within 4 weeks before starting protocol therapy.
- •2.Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
- •3.Colonic stent.
- •4.Contraindications for magnetic resonance imaging (MRI), such as cardiac pacemakers.
- •5.Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).
- •6.Active multiple cancers (simultaneous or metachronous multiple cancers with a disease-free interval 5 years or over). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can be cured by local treatment, are not considered active multiple cancers.
- •7.Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.
- •8.Hepatitis B (HB) antigen positive or Hepatitis C virus (HCV) antibody positive. However, HCV-RNA-negative can be registered.
- •9.Positive for human immunodeficiency virus (HIV) infection.
- •10.Received live vaccine within 30 days prior to the start of study drug administration.
- •11.With complicated autoimmune disease or a history of chronic or recurrent autoimmune disease.
- •12.With administration of systemic corticosteroids (except for prophylactic administration for examination or allergic reactions or temporary use to reduce edema associated with radiation therapy) or immunosuppressive agents, or has received such treatment within 14 days prior to enrollment in this study.
- •13.With unhealed wounds, ulcers, or fractures.
- •14.Unwillingness or inability to comply with the clinical trial protocol.
- •15.Other patients that the principal investigator or co-investigator deems ineligible for this study.
研究者
相似试验
进行中（未招募）
2 期
A single center, phase 2 study to evaluate safety and efficacy of total neoadjuvant treatment of short course radiotherapy followed by chemotherapy, capecitabine combined with oxaliplatin (CAPOX) for locally advanced rectal cancerRectal cancerlocal advanced rectal cancer, total neoadjuvant therapy, radiation therapy, chemotherapy, surgeryJPRN-jRCTs051200113Kagawa Yoshinori27
招募中
2 期
A single center Phase II study for the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma.JPRN-UMIN000041182Ogaki municipal hospital10
已完成
2 期
A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phaseChronic myelogenous leukemiaJPRN-UMIN000002007Shimousa Hematology Study Group40
进行中（未招募）
2 期
Prospective trial to evaluate the safety and efficacy to treat esophageal cancer using 5-FU, Oxaliplatin, and DocetaxelJPRN-jRCTs031200094Kawakubo Hirofumi60
招募中
2 期
A study of clofarabine combination therapy for infant AJPRN-jRCTs041190043Miyamura Takako42