KCT0007574尚未招募未知
A Phase II Study of Fecal Microbiota Transplantation with Nivolumab in Patients with Advanced Solid Cancers Who Have Progressed during Anti-PD-(L)1 Therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Donor inclusion criteria
- •1.Sex: Male or female
- •2.Age (at the time of informed consent): 19 years and older
- •3.Subjects with histologically- or cytologically-confirmed solid cancer
- •In case of hepatocellular carcinoma, clinically confirmed diagnosis as per the American Association for the Study of Liver Diseases (AASLD) is allowed.1
- •4.Patients who currently maintain a CR, PR or SD per RECIST v1.12 for at least 6 months with anti-PD-(L)1 monotherapy for solid cancer
排除标准
- •Donor exclusion criteria
- •1.Having taken antimicrobials (antibiotics, antivirals antifungals) in the 4 weeks prior to donation
- •2.Positive result for any pathogen determined in stool tests during the screening period (Table 3)
- •3.Current gastrointestinal symptoms including diarrhea, nausea, or vomiting
- •4.History of chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or irritable bowel syndrome
- •5.History of systemic autoimmune disease (e.g., multiple sclerosis, connective tissue disorder, type I diabetes mellitus)
- •6.History of significant neurological (except for chemotherapy-induced neuropathy), neurodegenerative, neurodevelopmental, or psychiatric disorders
- •7.History or risk behaviors for infectious disease:
- •History of HIV, syphilis, human T-lymphotropic virus I and II
- •Current systemic infection
- •Enteric pathogen infection in the last 8 weeks
- •Vaccination with a live attenuated virus in the last 8 weeks
- •Previous tissue/organ transplant
- •Recent travel (3 months) to tropical countries, countries with endemic diarrheal diseases or high risk of traveler’s diarrhea (Africa, Southeast Asia, Mexico, Central America, South America, Caribbean)
- •Recipient Exclusion criteria
- •1.Patients with active malignancy within the previous 2 years before study entry (with the exception of completely resected non-melanoma skin cancer, curatively treated carcinoma in situ or intramucosal carcinoma, superficial bladder cancer treated with curative intent, localized prostate cancer treated with curative intent or other cancers that are less likely to influence on their prognosis such as localized thyroid papillary carcinoma)
- •2.Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the study treatment in the opinion of the investigator or sub-investigator.
- •3.Patients with current or past history of severe hypersensitivity to any other antibody products
- •4.Patients with active autoimmune disease with systematic treatment (i.e., immunomodulator, corticosteroid, or immunosuppressant) required within the past 2 years before study entry.
- •?Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy due to dysfunction of adrenal gland or pituitary gland, etc.) is not regarded as a form of systematic treatment and would be allowed.
- •?Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible provided that they meet the following conditions:
- •–Rash must cover less than 10% of the body surface area.
- •–Disease is well controlled at baseline and only requires low potency topical steroids.
- •5.Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
- •6.Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative or inflammatory disease (e.g., Crohn´s disease or ulcerative colitis)
- •7.Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be enrolled if the metastasis is asymptomatic and requires no treatment.
- •8.Patients with uncontrollable pericardial fluid, pleural effusion, or ascites requiring
研究者
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