None listed
Conditions
Interventions
Drug, Procedure/Surgery : 1,Procedure of FMT
Recipients will undergo an initial native microbiota depletion phase in which they will receive oral antibiotics (Augmentin®: amoxicillin clavulanate
625 mg po tid) for 5 days (D-5 to D-1) before FMT treatment (D1). The last dose of Augmentin should be completed at least 12 hours (± 2 hours) prior to the administration of FMT stool through colonosc
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 frequent drainage (recurre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR by RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Progression Free Survival per iRECIST;Disease control rate per iRECIST;Overall Survival | — |
Countries
Korea, Republic of
Contacts
Public ContactSeyoung Seo
Asan Medical Center
Outcome results
None listed