esophageal cancer
Conditions
Interventions
??? Intervention group:Prebiotics combined with carbarizumab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75; 2. The patients with esophageal squamous cell carcinoma confirmed by histology or cytology and local advanced stage unresectable or with distant metastasis; 3. The secretion of IFN - ? by T cells increased by 20%; 4. Patients who failed to receive first-line systemic chemotherapy or radical synchronous radiotherapy and chemotherapy; Definition of treatment failure: during or after the treatment of first-line systemic chemotherapy or radical synchronous radiotherapy and chemotherapy, there must be imaging evidence or clinical evidence to prove the disease progress; for neoadjuvant / adjuvant treatment, if the disease progress occurs during the treatment or within 6 months after the treatment is stopped, it should be regarded as first-line treatment failure; 5. Those patients who have at least one evaluable focus according to recist1.1 and have not received radiotherapy or other local treatment (target focus located in the previous radiotherapy area can also be selected as target focus if it is confirmed that it has progressed and meets recist1.1 standard); 6. Patients with ECOG-ps: 0-1; 7. Patients whose functions of important organs meet the following requirements: Neutrophil count (ANC) = 1.5 × 109 / L; hemoglobin (HB) = 90g / L; platelet count = 75 × 109 / L; serum albumin = 28g / L; bilirubin = 1,5 × upper normal limit (ULN); total bilirubin = 30mmol / L; aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 times ULN; alt, AST = 5 times ULN in the presence of liver metastasis; Serum creatinine = 1.5 × normal; amylase and lipase = 1.5uln; upper limit of INR = 1.5; routine urine test: urine protein < + + or 24-hour urine protein quantity = 1g. 8. Doppler echocardiography: left ventricular ejection fraction (LVEF) = 50%; 9. Patients who are willing and able to comply with the agreement by providing written informed consent; 10. Female subjects with fertility should be tested for urine or serum pregnancy within 72 hours before receiving the first study drug, which is proved to be negative, and they are willing to take effective contraception within 3 months from the test period to the last administration of carrizumab.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-tumor chemotherapy, radiotherapy, targeted small molecule therapy or the adverse events caused by the previously received drugs within 4 weeks before the first use of the study drug have not recovered (i.e., must be = level 1 or reach the baseline level), except for the subjects with grade 2 neuropathy or grade 2 alopecia. For patients undergoing major surgery, the toxicity and / or complications caused by surgical intervention must be fully recovered before the study drug treatment; 2. Patients with a previous treatment history (within 6 months prior to inclusion in the study) or who are currently using other probiotic treatments. 3. Patients who have previously received immunotherapy for PD-1 / PD-L1; 4. Subjects who received live attenuated vaccine within 4 weeks before the first use of the study drug; 5. Patients who received antibiotic treatment for any reason within one week; 6. Subjects who required systematic treatment with corticosteroids (> 10mg / day of prednisone) or other immunosuppressants within 14 days before the first use of the study drug. In the absence of active autoimmune disease, it is allowed to inhale or topically use corticosteroids with a therapeutic dose of > 10mg / day prednisone; 7. Subjects with central nervous system metastasis; 8. Subjects with any previous organ transplantation; 9. Patients with severe gastrointestinal bleeding or active hemoptysis 1 month before admission; 10. Subjects with severe gastrointestinal malabsorption and diarrhea; 11. Patients with a history of active autoimmune disease or autoimmune disease (such as multiple sclerosis, systemic lupus erythematosus). Subjects with vitiligo or alopecia were allowed. Patients with psoriasis and childhood asthma who have been completely relieved and do not need any intervention can be included; 12. Patients with history or evidence of interstitial lung disease or active noninfective pneumonia; 13. Patients with uncontrolled clinical symptoms or diseases of the heart, such as NYHA class II or above heart failure, unstable angina, myocardial infarction within one year, clinically significant supraventricular or ventricular arrhythmia, need clinical intervention; 14. Patients with other malignant tumors in the past 5 years (except for melanoma in situ, basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, breast carcinoma in situ, which have been effectively treated); 15. Patients with acquired immune deficiency (such as HIV infected patients), active hepatitis B (HBV-DNA = 104 copies / ml) or hepatitis C (HCV antibody positive, and hcv-dna higher than the detection limit of the analysis method) after the first day; 16. Patients with active infection or unknown fever > 38.5 ? before the first administration during the screening period (according to the judgment of the researcher, the fever caused by tumor can be included in the group); 17. Objects known to be allergic to any of the ingredients of any of the clarizumab or Lactobacillus paracasei preparations; 18. Subjects participating in other clinical trials 4 weeks before the first use of the study drug; 19. Pregnant or lactating women; According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases requiring combined treatment, severe laboratory test value abnormality, family or social factors, whi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
china
Contacts
Public ContactCui Kang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed