liver cancer
Conditions
Interventions
Experimental group:pd1 combined with intestinal flora
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Primary liver cancer diagnosed by histology that cannot be surgically removed or cured by radiotherapy and chemotherapy, with pathological type or clinical diagnosis of hepatocellular carcinoma; 3. Subjects with advanced liver cancer have used antibiotics (anti-G- and G+ bacteria) for at least one week within 90 days; 4. Baseline assessment according to RECIST v1.1 standard includes assessment of index lesions and non-index lesions, and the total number of baseline index lesions should not exceed 15, including: up to 10 internal organ lesions (no more than 5 lesions per organ) and 5 skin lesions, the basic standard for the inclusion of index lesions is: no less than 5mm x 5mm, and the sum of the largest cross-sectional area is extended as the basis for quantitative evaluation. Selection criteria for non-indicator lesions: those that do not meet the measurement size standard, those that meet the measurement standard but exceed the total number of inclusion criteria in the same organ (if there are more than 5 measurable lesions), and are defined as unmeasurable lesions; 5. ECOG: 0-3 within 7 days before the first administration of the study drug; 6. Expected survival period >= 12 weeks; 7. The functions of vital organs meet the following requirements: absolute neutrophil count (ANC) >= 1.5x10^9/L; platelets >= 100x10^9/L; total bilirubin 60 mL/min (calculated by the Cockcroft-Gault formula); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) <= 1.5 x ULN; 8. Female subjects with fertility, the blood pregnancy test must be negative within 7 days before the first dose, male subjects whose partners are females of childbearing age are required to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptives, or condoms) during study treatment; 9. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with gastrointestinal obstruction and inability to receive enteral nutrition through oral or nasal feeding; 2. Patients with systemic inflammatory response syndrome (SIRS) or uncontrolled intestinal infection who used antibiotics 3. Patients with central nervous system metastasis; 4. Patients who have a history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); With the exception of vitiligo or cured childhood asthma/allergies without any intervention in adults; Autoimmune-mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type I diabetes with a steady dose of insulin; 5. Patients who have a history of immunodeficiency, including positive HIV antibody test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; 6. The patients who have cardiovascular without control and have clinical symptoms or disease, such as: (1) the NYHA class II above heart failure;(2) unstable angina pectoris;(3) unstable angina occurred within six months chamber (4) have clinical significance of myocardial infarction (mi) on sexual or ventricular arrhythmia without clinical intervention or poorly controlled clinical intervention; 7. Patients who have severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization; Baseline chest imaging examination suggests active pulmonary inflammation with clinically relevant symptoms or signs; The presence of signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in the case of prophylactic use of antibiotics; 8. Patients with prior and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe pulmonary impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity; Patients with radiation pneumonia in last 6 months; 9. Patients who have active or suspected autoimmune diseases. The patients 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. Patients 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 patients 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. And hepatitis C (positive HCV antibody test and positive HCV-RNA); 12. Lactating patients; 13. According to the judgment of the investigator, the patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune function assessment;16s gut flora health assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLi Suyi
Anhui Provincial Cancer Hospital
Outcome results
None listed