Colorectal cancer
Conditions
Interventions
"Enterobacteria capsule" group:Take in 16 enteric capsule
placebo group :Placebo capsules that are administered orally in the same amount as "Enterobacteria capsules"
Sponsors
Department of Gastroenterology of Army Specialized Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years, gender is not limited; (2) Patients with metastatic colon or rectal adenocarcinoma diagnosed by histology have metastatic/recurrent lesions that cannot be cured by surgery; (3) At least one measurable lesion according to the RECIST 1.1 standard; (4) Previous systemic anti-tumor therapy for mCRC (including systemic chemotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, radiation therapy, topical therapy, and other research and treatment drugs); (5) Subjects who have undergone postoperative adjuvant chemotherapy should first find recurrence or metastasis for >= 6 months after the end of the last dose of adjuvant chemotherapy; (6) Tissue samples shall be provided for biomarker (eg PD-L1) analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 10-15 pieces of >= 5um thick paraffin sections that are archived and preserved; (7) ECOG: 0 to 1 point; (8) The expected survival period is >= 3 months; (9) The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of screening test): Absolute neutrophil count (ANC) >=1.5 x 10 ^ 9 / L; platelets >= 90 x 10^9/L; hemoglobin >= 10g/dL; serum albumin >= 2.8g/dL; total bilirubin = 50mL / min (calculated according to the Cockcroft-Gault formula); (10) No other gastrointestinal diseases, no mental illness; (11) A female subject with fertility should undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and is shown to be negative and willing to be between the trial period and 3 months after the last dose. Use effective methods for contraception. For male subjects whose partners are women of childbearing age, effective methods should be used during the test period and within 3 months after the last dose; (12) Subjects voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion criteria
Exclusion criteria: (1) Previous systemic anti-tumor treatment for metastatic colorectal cancer (including systemic chemotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, and other research and treatment drugs); (2) Subjects with recurrent and metastatic lesions who can undergo radical surgery; (3) There have been major operations or incisional biopsy or major trauma within 4 weeks before the first use of the drug; (4) existing brain metastasis or pial meningeal; (5) Have bleeding tendency, high risk of bleeding or coagulopathy, history of thrombotic disease within 6 months and/or hemoptysis within 3 months (at least 1/2 teaspoon of about 2.5 ml of blood per cough); Treatment with a full-dose oral or parenteral anticoagulant or thrombolytic agent (allows prophylactic use of anticoagulants); aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory that inhibits platelet function within 10 days Drug; CT/MRI images show tumors surrounding or invading the lumen of large blood vessels (such as the pulmonary artery or superior vena cava); (6) poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), as well as subjects with previous history of hypertensive crisis or hypertensive encephalopathy; severe cardiovascular and cerebrovascular diseases, including inclusion Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within the first 6 months; Stable angina, New York Heart Association (NYHA) classification of grade >= grade 2 heart failure and severe arrhythmias beyond drug control; (7) Non-healing wounds, active peptic ulcers or fractures, active infections, tracheal-esophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intra-abdominal abscess within 6 months; (8) Have any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism ( Hormone replacement therapy can be included after it is effective); patients with vitiligo or have been completely relieved in childhood and can be included without any intervention after adulthood, and asthma patients who require bronchodilators for medical intervention are not included; (9) There is active infection or unexplained fever within 3 weeks before the first dose>38.5 degree C (the subject can be enrolled due to fever caused by the tumor); (10) A history or evidence of non-infectious pneumonia known to have interstitial lung disease or in the presence of corticosteroids; (11) suffering from congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copy number/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and high HCV-RNA) The lower limit of detection of the analytical method); (12) It is known to be allergic to any SHR-1210 component, or to allergic reactions, hypersensitivity reactions or contraindications to BP102 and chemotherapeutic drugs (oxaliplatin, capecitabine) or any component thereof used in the formulation; (13) Within 4 weeks prior to the first use of the study drug (subjects who have entered the follow-up period are counted at the time of the last use of the test drug or device) or are participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of 16s rRNA intestinal flora;DFS;OS;PFS;TTP; | — |
Countries
China
Contacts
Public ContactYanling Wei
Department of Gastroenterology of Army Specialized Medical Center
Outcome results
None listed