Locally advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction
Conditions
Interventions
Treatment group:Fruquintinib + Cadonilimab + SOX/FOLFOX
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for enrollment: 1. Patients must meet all of the following inclusion criteria to be enrolled in this study: 2. Patients voluntarily join this study, sign informed consent, and are able to comply with the visits and related procedures specified in the protocol; 3. Age: = 18 years old and = 75 years old, both male and female; 4. All subjects must be locally advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction confirmed by histopathological examination. 5. First-line treatment of adenocarcinoma of the stomach and gastroesophageal junction; 6. If immunotherapy is used in the neoadjuvant/transformational/adjuvant stage, with an interval of more than 6 months, the first-line enrollment is also allowed; 7. Acute toxicity and side effects caused by prior medical therapy or surgery have all recovered to grade 0-1 (NCI-CTCAE version 5.0) or reached the level specified in the inclusion/exclusion criteria; 8. Toxicities identified by the investigators that do not pose a safety risk to the patient are excluded, such as alopecia, etc.; 9. At least one measurable lesion by CT or MR without local treatment (according to iRECIST v1.1); 10. First-line therapy may be enrolled regardless of microsatellite status of MSS/pMMR or MSI-H/dMMR. 11. HER2 negative; 12. ECOG score: 0~1; 13. Expected survival = 6 months; 14. The function of vital organs meets the following requirements: • Absolute neutrophil count = 1.5×10 9/L; • Platelet = 80×10 9/L; •Hemoglobin = 90 g/L; •Serum albumin = 28 g/L; •Thyroid-stimulating hormone (TSH) =1× ULN (if abnormal, FT3 should be investigated at the same time, FT4 levels, if FT3 and FT4 levels are normal, they can be enrolled); • Bilirubin =1.5×ULN (within 7 days prior to the first dose); The = of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 2.5 times the upper limit of normal (ULN) (without liver metastases), and the = of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 5 and 3 times higher than the upper limit of normal (ULN) (with liver metastases); •AKP= 2.5×ULN; •Serum creatinine = 1.5 × ULN; or creatinine clearance (Ccr) =40 mL/min (calculated using the Cockcroft/Gault formula): Female: CrCl = (140-years) x body weight (kg) x 0.85 72 x serum creatinine (mg/dL) Male: CrCl = (140-years) x body weight (kg) x 1.00 72 x serum creatinine (mg/dL) •Anticoagulation-naïve subjects: INR or APTT=2×ULN. •Urine protein < 2+; If the urine protein = 2+, a 24-hour urine should be collected and the urine protein content should be measured < 1.0 g/24 hours. 15. Non-surgically sterilized female patients of childbearing potential
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in this study: 1. Is participating in a clinical study and receiving treatment, or has participated in other experimental drug studies within 4 weeks prior to starting this study drug, and has received study treatment or has received trial medical treatment and has undergone major surgical surgery within 4 weeks prior to randomization, and has not recovered from the side effects brought about by the above operations. 2. Patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patient has vitiligo; Asthma that has been completely resolved in childhood and does not require any intervention in adulthood may be included; Asthma in patients requiring medical intervention with bronchodilators could not be included); Replacement therapy is not considered systemic therapy, and the following patients may be enrolled: those with a history of autoimmune-related hypothyroidism who have received thyroid hormone replacement therapy; Type I diabetes mellitus that can be controlled with insulin therapy. 3. The interval between previous chemotherapy treatments with Tigio, oxaliplatin, and fluorouracil is less than 6 months. 4. Prior treatment with fruquintinib-targeted drugs and cadonilimab at less than 6 months. 5. Any active malignancy within 5 years, except for the specific cancers being studied in this trial and localized tumors that have been cured, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate, etc. 6. The patient has an active infection, has an unexplained fever =38.5°C) within 7 days before medication, or has a baseline white blood cell count >15×10 9 /L; Any serious acute or chronic infection requiring the use of systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) at screening, with the exception of active hepatitis. 7. As judged by the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the patient's safety. 8. Patients with congenital or acquired immunodeficiency (e.g., HIV-infected); 9. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). 10. Active hepatitis B is defined as the known HBsAg positive result and HBV-DNA > 2000IU/ml. Active hepatitis C is defined as a known positive hepatitis C antibody with HCV RNA quantification results above the lower limit of detection of the analytical method. For active hepatitis, if subject HBV DNA < 500IU/mL (or 2500 copies/mL) at screening. 11. Have a history of severe cardiovascular and cerebrovascular diseases: (1) New York Heart Association (NYHA) cardiac function grade III, IV heart failure within 6 months before the drug application; (2) Left ventricular ejection fraction <50%; (3) Drugs are difficult to control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;Overall survival; | — |
Countries
china
Contacts
Public Contactzhaoda
The First Hospital of Lanzhou University
Outcome results
None listed