Colorectal Cancer
Conditions
Interventions
Experimental group:Fecal Microbiota Transplantation combined with Immune Checkpoint Inhibitors and Bevacizumab
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient has good compliance, can understand the research process of this study, and sign the written informed consent; 2. Aged >= 18 years; 3. Expected survival period >= 6 months; 4. Histological or cytological diagnosis of rectal adenocarcinoma, patients with non-surgical indications; 5. ECOG score = 1.5x10^9/L; (2) Platelets >= 100 x 10^9/L; (3) Total bilirubin 60 mL/min (calculated by Cockcroft-Gault formula); (7) Activated partial thromboplastin time (APTT), international normalized ratio (INR) and prothrombin time (PT) <= 1.5 x ULN. 9. Non-pregnant or lactating women; women/men of childbearing age should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment.
Exclusion criteria
Exclusion criteria: 1. Those who have received other types of immune checkpoint inhibitors in the past; 2. Have been vaccinated with live virus vaccine within 30 days before treatment; 3. Past history of malignant tumors, except those who have been cured and have no evidence of disease recurrence within 5 years after starting treatment; 4. Associated with known active central nervous system metastases and/or cancerous meningitis; 5. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including 6. these diseases or syndromes); patients with no intervention in adulthood except for vitiligo or cured childhood asthma/allergies; autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones; use of stable doses of Type I diabetes with insulin; 7. Have a history of immunodeficiency, including a positive HIV antibody test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 8. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: such as: (1) NYHA class II or above heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 6 months; (4) Clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without clinical intervention or after clinical intervention. 9. Those who have experienced severe allergic reactions to other monoclonal antibody therapy; 10. Are receiving long-term systemic steroid therapy. Patients with asthma requiring intermittent use of bronchodilators, inhaled steroids, or topical steroid injections are not excluded; 11. There are active infections requiring treatment; 12. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment; 13. Subjects with hepatitis B surface antigen HBsAg (+) and/or hepatitis B core antibody (HBcAb) (+), HBV-DNA >= 500 IU/mL or 2500 copies/mL at the time of enrollment; 14. Received probiotics or antibiotic-related products within the past 14 days; 15. Pregnancy or breastfeeding, or pregnancy during study drug treatment and within the required contraceptive period after the last dose of study drug; 16. Other circumstances that the researcher deems inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of intestinal flora quantity;15 immune functions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;objective response rate;overall survival; | — |
Countries
China
Contacts
Public ContactShen Tao
Yunnan Cancer Hospital
Outcome results
None listed