Lung adenocarcinoma
Conditions
Interventions
Intestinal flora transplantation group:The subjects received a course of PD-1 antibody combined with cisplatin and pemetrexed, and the feces of the subjects were collected and sequenced to select the
One course of intestinal flora transplantation (FMT) was performed one week before the start of the second course of treatment (3 times, every other day, 40g of flora each time). The transplanted bact
After bacterial population transplantation, PD-1 antibody combined with cisplatin and pemetrexed induction therapy was completed, and PD-1 antibody combined with pemetrexed or PD-1 antibody monotherap
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Advanced, metastatic or recurrent lung adenocarcinoma confirmed by histology or cytology as advanced (IIIB/IIIc/IV), unresectable and unable to accept radical concurrent chemoradiotherapy; 2. The patient is able and willing to provide pathological tissues embedded in wax blocks or paraffin sections; 3. The expression of PD-L1 was 0; 4. Have not received any systematic anti-tumor treatment for advanced/metastatic diseases in the past; Patients who have previously received platinum containing adjuvant chemotherapy, neoadjuvant chemotherapy or radical chemoradiotherapy for advanced diseases are eligible to participate in this study if the disease progression occurs more than 6 months after the end of the last treatment; 5. According to RECIST v1.1 standard, the recruited subjects had measurable lesions; 6. ECOG performance status is 0 or 1; 7. Aged 18-75 years old; 8. Life expectancy > 3 months; 9. Within 14 days before the first study treatment, the patient must have the appropriate organ function defined by the following laboratory results: (1) Absolute neutrophil count >= 1500/mm³; (2) Platelet >= 100000/mm³; (3) Hemoglobin > 9 g/dL (blood transfusion allowed); (4) Creatinine clearance rate > 60 mL/min; (5) Bilirubin <= 1.5 x upper normal limit (ULN) (unless Gilbert syndrome allows 3 x ULN); (6) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN (unless liver metastasis is recorded, it is allowed to be <= 5 x ULN); (7) Alkaline phosphatase (ALP) <= 2.5 x ULN (unless there is documented bone or liver metastasis, where <= 5 x ULN is allowed); (8) International normalized ratio (INR), prothrombin (PT) and prothrombin time (PTT) <= 1.5 x ULN (unless the subject is receiving anticoagulation therapy); 10. Female subjects of childbearing age need to take effective contraceptive measures during the whole treatment period and 6 months after the treatment period; 11. During the study, the patients were willing and able to comply with the study protocol, including treatment and scheduled visits and examinations including follow-up; 12. The patient/Guardian voluntarily participated in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. NSCLC diagnosed with EGFR-sensitive mutation or ALK gene rearrangement; 2. Received approved systemic anticancer therapy, including hormone therapy, within 28 days prior to initiation of study therapy; 3. Previous acceptance of EGFR inhibitors or ALK inhibitors; 4. Have received PD-1 or PD-L1 targeted therapy; 5. Received systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer (prior cancer vaccine is permissible); 6. Had received Chinese herbal medicine or proprietary Chinese medicine for cancer control in the 14 days prior to randomization; 7. History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 8. Clinically serious pericardial effusion; 9. There were clinically uncontrolled pleural effusion or ascites requiring drainage by pleural puncture or abdominal incision within 2 weeks before randomization; 10. Severe chronic or active infections, including tuberculosis, that require systemic antibacterial, antifungal or antiviral treatment; 11. Active pia meningeal disease or uncontrolled and untreated brain metastases: 12. Had any major surgery within = grade 2 had occurred within <= 6 months prior to randomization; (6) had a cerebrovascular accident (CVA) within <= 6 months before randomization; 21. Have previously undergone allogeneic stem cell transplantation or organ transplantation; 22. Had received live vaccine within <= 4 weeks prior to randomization; 23. There is an underlying medical condition or a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);6-month Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Overall Survival;Duration of Response;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactChen Kai
The First Affiliated Hospital of Soochow University
Outcome results
None listed