Treated advanced metastatic MSS/pMMR colorectal cancer
Conditions
Interventions
Test group(group A):Fecal microbiota transplantation
Control group (group B):Placebo
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Metastatic, histologically confirmed, unresectable pMMR/MSS colorectal adenocarcinoma (stage IV, as defined by the AJCC eighth edition) [National Comprehensive Cancer Network 2018]. Known Ras and Raf mutation status, TMB, and PD-L1 expression were required. 2. At least one measurable lesion was assessed according to RECIST 1.1 criteria. 3. He had received fluorouracil, irinotecan, and oxaliplatin before disease progression or intolerance. Previous treatment could be combined with or without anti-VEGF monoclonal antibody. For Ras WT subjects with left-sided colorectal tumors, at least one anti-EGFR monoclonal antibody (cetuximab or cetuximab ß) was used. 4. Age >=18 years old and =90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count >=100×10^9 per liter (patients must not have received blood transfusions or growth factor support within 14 days after blood sample collection); b. ALT, AST =60ml/min/1.73m^2;e. Serum albumin >=30g/L; f. An international normalized ratio (INR) or prothrombin time (PT) of 1.5 times ULN or less, unless the patient is receiving anticoagulant therapy and the PT value is within the intended anticoagulant range; g. Activated partial thromboplastin time (aPTT) =50%. 8. Written informed consent was obtained, and the patients understood that they could withdraw from the study at any time. 9. Women of childbearing potential had to have a negative urine or serum test for pregnancy within 7 days before enrollment and had to agree to use a highly effective contraceptive method for the duration of the study and for at least 120 days after the last dose of either fuquinitinib or apalorito volrelizumab. 10. Unsterilized men had to agree to use highly effective contraception for the duration of the study and for at least 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with immune checkpoint inhibitors (including but not limited to anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CTLA-4, anti-LAG-3 and other drugs) was performed. 2. Patients with active autoimmune disease or a history of autoimmune disease with possible relapse. Patients with the following conditions were not excluded and were eligible for further screening: a. controlled type 1 diabetes; b. hypothyroidism (if controlled with hormone replacement therapy alone); c. controlled celiac disease; d. Skin diseases requiring no systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease that is not expected to recur in the absence of an external trigger. 3. Any active malignancy within 2 years, excluding the specific cancers that were being investigated in the trial and cured, locally recurrent cancers (e.g., resected basal-cell or squamous-cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 4. Uncontrolled pleural, pericardial, or ascites requiring frequent drainage was present within 14 days before enrollment (confirmed by effusion cytology was allowed). 5. Patients had gastrointestinal bleeding within 2 weeks before enrollment or were considered by the investigator to be at high risk for bleeding. 6. Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment. 7. Weight loss >= 20% within 2 months before enrollment. 8. Clinically significant lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc. 9. There were uncontrollable systemic diseases including diabetes mellitus and hypertension. 10. "Severe chronic or active infections, including tuberculosis, HIV infection, etc., requiring systemic antimicrobial, antifungal, or antiviral therapy." 11. Patients with untreated chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA > 1000 IU/mL or hepatitis C virus (HCV) RNA positive should be excluded. "Inactive hepatitis B surface antigen (HBsAg) carriers, treated patients with stable hepatitis B (HBV DNA =2 or concomitant supraventricular tachyarrhythmias requiring medical therapy occurred <= 6 months before enrollment. f. Cerebrovascular accident (CVA) occurred within 6 months before enrollment. 13. He had undergone allogeneic stem-cell transplantation or organ transplantation. 14. Patients requiring systemic treatment with corticosteroids (prednisone at a dose higher than 10 mg per day or equivalent) or other immunosuppressive agents within 14 days or less before enrollment. 15. Patients were treated with systemic antineoplastic drugs within 28 days, palliative radiotherapy and Chinese herbal medicine within 14 days, and oral intestinal microflora modulators within 1 week before enrollment. 16. Other conditions considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;objective response rate;disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactMeiqin Yuan
Zhejiang Cancer Hospital
Outcome results
None listed