Gastric adenocarcinoma
Conditions
Interventions
Experimental Group:Cardonimumab 10mg/kg
Irinotecan liposomes 70mg/m ^ 2
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, male or female; 2. Patients with locally advanced or metastatic HER-2 negative gastric adenocarcinoma confirmed by histopathology or cytology; 3. Failure of previous first-line systemic therapy, if any of the following criteria were met: a) patients received =1 cycle of previous first-line systemic therapy and had disease progression according to RECIST 1.1 criteria during or within 6 months after treatment; b) RECIST-1.1 defined disease progression or relapse during or within 6 months after prior neoadjuvant or adjuvant therapy; 4. At least one measurable lesion that can be repeatedly measured according to RECIST v1.1; 5.ECOG score 0-2; 6. Expected survival time =3 months; 7. Adequate organ function: specific bone marrow function: neutrophil (ANC) =1.5×10^9/L, platelet (PLT) =100×10^9/L, hemoglobin (Hb) =90g/L, white blood cell (WBC) =3.0×10^9/L; Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) =2.5×ULN; Total bilirubin =1.5×ULN; Renal function: serum creatinine (Cr) =1.5×ULN or creatinine clearance =60 ml/min (calculated by Cockroft-Gault); 8. Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose; 9. If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective method of contraception from the start of screening until 120 days after the last dose of medication; 10. Understand the situation of this study, patients and/or their legal representatives voluntarily agree to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Her-2-positive gastric adenocarcinoma (defined as local IHC 3+ or 2+/ISH amplification positive); 2. Received systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks before the study treatment; 3. Major surgical treatment (as determined by the investigator), open biopsy, or major trauma within 4 weeks before the first dose; Or requiring elective major surgical treatment during the study period; 4. Known active brain metastases; 5. Previous treatment with irinotecan, irinotecan liposome, anti-CTLA-4 antibody, or cadunilumab; 6. Previous grade III-IV immune AE, such as immune myocarditis, immune hepatitis, immune pneumonia, etc. 7. Subjects with uncontrolled pleural, pericardial or peritoneal effusion requiring repeated drainage more than once a month; 8. Patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 3 years; 9. Have an active autoimmune disease requiring systemic treatment within the past two years; Patients with a history of interstitial lung disease or noninfectious pneumonia requiring systemic glucocorticoids; 10. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia; 11. History of severe bleeding tendency or coagulopathy; 12. Blood donation or massive blood loss (> 400 mL) within 90 days before the first dose; 13. Presence of severe gastrointestinal diseases (including active bleeding, grade 1 or above obstruction, or grade 1 or above diarrhea [CTCAE v5.0]); 14. Known to be allergic or intolerant to therapeutic drugs or their excipients; 15. Have an uncontrolled concurrent medical condition including, but not limited to, persistent or active infection, symptomatic congestive heart failure, watery stools, central nervous system disease, or psychiatric illness/social condition that would limit adherence to study requirements or be judged by the investigator to be ineligible for the study; Active, uncontrolled bacterial, viral or fungal infection requiring systemic treatment, defined as persistent signs/symptoms associated with the infection that do not respond despite the use of appropriate antibiotics, antiviral therapy and/or other treatments; 16. Known active HIV infection (i.e., HIV1/2 antibody-positive); Untreated active HBV infection (defined as HBsAg positivity with HBV-DNA copies greater than the upper limit of the normal range in the laboratory at the participating center) and HCV infection (HCV antibody positivity with an HCV-RNA level greater than the upper limit of the normal range); 17. Received any study medication within 3 weeks before starting study treatment; 18. Use of strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1; 19. Pregnant or lactating women and patients of childbearing age who declined appropriate contraception during the course of the trial; 20. Patients judged by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;During of response;Time to Treatment Failure; Overall Survival;safety; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiangsu Cancer Hospital
Outcome results
None listed