Esophagus cancer
Conditions
Interventions
Experimental group:PD1+FMT
Control group:PD1+ targeted agents or chemotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, Aged 18 to 75 years. 2.Pathologically or clinically diagnosed as hepatocellular carcinoma and Confirmed curable to do radiotherapy / chemotherapy, or surgery 3.The patient who get Two-line chemotherapy and above patients , The patient who get Have used antibiotics (anti-G - and G+ bacteria) at least a week in the last 90 days; 4.According to RECIST v1.1 standard, baseline assessment includes both target lesions and non-target lesions. The total number of baseline target lesions is no more than 15, including: 10 visceral organ lesions at most (no more than 5 lesions for each organ) and 5 skin lesions. The basic criteria for inclusion of target lesions are: It is not less than 5mm×5mm, and the sum of the maximum cross-sectional area is used as the basis for quantitative evaluation. Selection criteria for non-index lesions: those that did not meet the measurement size criteria, those that met the measurement criteria but exceeded the total inclusion criteria (5 > lesions in the same organ) and those that were defined as immeasurable lesions. 5.ECOG score =12 weeks; 7.Good organ function:((ANC)>=1.5x10^9/L;PLT>=100x10^9/L;TBIL60 mL/min(Cockcroft-Gault);APTT,INR,PT<=1.5 x ULN 8.Fertile female subjects must have a negative blood pregnancy test in 7 days before used the first dose, and male patient with a female partner of reproductive age must use at least one medically approved contraceptive method (e.g. intrauterine device, contraceptive or condom) during the study treatment period; 9.The patient voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with gastrointestinal obstruction and unable to enteral nutrition through oral or nasogastric feeding; 2. Patients with systemic inflammatory response syndrome (SIRS) or uncontrolled intestinal infection who are using broad-spectrum antibiotics 3. Patients with central nervous system metastasis; 4. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to 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; 5. 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; 6. 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. 7. Subjects have severe pneumonia, bacteremia, infectious complications, etc. that require hospitalization; baseline chest imaging examinations indicate active pulmonary inflammation accompanied by clinically relevant symptoms or signs; 2 weeks before the first use of the study drug The presence of signs and symptoms of infection, or the need for oral or intravenous antibiotics, unless prophylactic antibiotics are used; 8. Subjects with past and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function, etc. that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; subjects with radiation pneumonitis within 6 months examinee; 9. The subject has known active or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are allowed to be enrolled; 10. 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; 11. 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. For those higher than this standard, unless they first receive antiviral treatment and are required to drop to the normal range for at least 2 weeks, they must continue to receive antiviral treatment throughout the study period before they can be enrolled. For subjects who need to receive or are receiving antiviral therapy at the time of screening, even if HBV-DNA is eligible for inclusion, they must continue to receive antiviral therapy throughout the study period to be included in the study. Hepatitis C (positive HCV antibody test and positive HCV-RNA); 12. Pregnant or lactating women; 13. According to the judgment of the investigator, the subject has
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16 Second intestinal microflora health assessment;Immune function; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;overall survival;Interleukin-6;Body composition analysis;safety; | — |
Countries
China
Contacts
Public ContactLi Suyi
Anhui Provincial Cancer Hospital
Outcome results
None listed