Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Fecal microbiota transplants combined with Camrelizumab
Sponsors
Meizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up. 2. Aged 18-75 years, no gender limit. 3. Esophageal squamous cell carcinoma (ESCC) was pathologically confirmed. 4. Disease progression occurs during or after at least first-line treatment of unresectable, locally advanced, recurrent, or metastatic ESCC. 5. Previous use of drugs containing carrilizumab was assessed as progress according to Recist1.1 criteria. 6. ECOG score 0-2. 7. At least one measurable lesion was assessed according to RECIST version 1.1. 8. Life expectancy >=3 months. 9. Normal major organ function, i.e. meeting the following criteria: (1) Absolute neutrophil count >= 1.5 x 10^9/L; Platelet count >= 75 x 10^9/L; Hemoglobin >= 9 g/dL; (2) Serum creatinine = 120 days after the last dose of study drug and to have a negative urine or serum pregnancy test within 14 days before enrollment. 11. Unsterilized men had to agree to use highly effective contraception for the duration of the study and for >= 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Patients who have received evidence of fistula (esophagobronchial or esophagoaortic or esophagomediastinal fistula). 2. There are significant factors affecting oral drug absorption, such as inability to swallow (except patients with indenture of nasal feeding gastrojejunal tube), intestinal obstruction. 3. Patients who are participating in other intervention studies. 4. Patients with other malignant tumors. Note: Participation in both observational and non-interventional studies is permitted. In addition, patients who have completed drug therapy in clinical studies and are in the follow-up period are eligible for this study. 5. Patients with active autoimmune disease or a history of autoimmune disease that may recur. Note: Patients with the following diseases may be further screened without being excluded: (1) Well-controlled type 1 diabetes. (2) Hypothyroidism (controlled by hormone replacement therapy alone). (3) Well-controlled celiac disease. (4) Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia). (5) Have been in remission and will not relapse into any other disease in the absence of external triggers. 6. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention). 7. Poorly controlled diabetes mellitus with grade 3 hypoalbuminemia was present before enrollment. 8. A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled lung disease, including pulmonary fibrosis and acute lung disease. 9. There are systemic infections (including tuberculosis infections, etc.) that require systemic antimicrobial, antifungal or antiviral treatment. Note: Patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are allowed to receive antiviral therapy. 10. The presence of untreated chronic hepatitis B or chronic HBV carriers with HBV DNA > 1000 IU/mL (or > 1000 copies /mL) at screening. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA 2 weeks prior to enrolling. 11. Patients with active hepatitis C. Note: Patients who tested negative for HCV antibodies at screening or who tested positive for HCV antibodies at screening but subsequently tested negative for HCV RNA were enrolled. HCV RNA testing will only be performed in patients who test positive for HCV antibodies. Patients who were receiving antiviral therapy at the time of screening should receive treatment for > 2 weeks prior to enrolling. 12. A known history of human immunodeficiency virus (HIV) infection. 13. Any major operations were performed no more than 28 days before enrollment. Note: If any major surgery was performed > 28 days prior to enrollment, the patient must have fully recovered from the toxicity and/or complications of the treatment prior to enrollment. 14. Previous allogeneic stem cell transplantation or organ transplantation. 15. Have any of the following cardiovascular risk factors: (1) Cardiogenic chest pain occurred <= 28 days before randomization, defined as moderate pain limiting instrumental activities of daily living. (2) Pulmonary embolism occurred <= 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactWu Guowu
Meizhou People's Hospital
Outcome results
None listed