gastric cancer or esophageal/gastric junction cancer
Conditions
Interventions
single arm:1. SOX+fruquintinib+sintilimab
2. XELOX+fruquintinib+sintilimab
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study, provided written informed consent, and were able to comply with the protocol-specified visits and related procedures; 2. Age: =18 years old and =75 years old, both male and female; 3. All subjects had to have primary resectable gastrointestinal tumors confirmed by histopathology or cytology; 4. Acute toxicity caused by previous drug therapy or surgery recovered to grade 0-1 (NCI-CTCAE version 5.0) or reached the level specified in the inclusion/exclusion criteria; 5. Toxicities that the investigators determined did not pose a safety risk to patients, such as hair loss, were excluded; 6. At least one lesion measurable on CT or MR Without local treatment (according to iRECIST v1.1); 7. ECOG score: 0-1; 8. Expected survival time =12 weeks; 9. The functions of vital organs meet the following requirements: Absolute neutrophil count =1.5×10 9 /L Platelet count =80×10 9 /L Hemoglobin =90 g/L Serum albumin =28 g/L Thyroid stimulating hormone (TSH) =1×ULN (FT3 and FT4 levels should be tested simultaneously if abnormal, and if FT3 and FT4 levels are normal, they can be included) Bilirubin =1.5×ULN (within 7 days before index dose) ALT and AST=3×ULN (within 7 days before index dose) AKP= 2.5×ULN Serum creatinine =1.5×ULN Or creatinine clearance (Ccr) =40 mL/min (calculated by Cockcroft/Gault formula) : Female: CrCl= (140- years) x weight (kg) x 0.85/72 x serum creatinine (mg/dL) Male: CrCl= (140-age) x weight (kg) x 1.00/72 x serum creatinine (mg/dL) For nonanticoagulated patients: INR or APTT=2×ULN Urinary protein < 2+ If the urine protein is =2+, the 24-hour urine should be collected and the urine protein content should be less than 1.0g/24 hours. 10. Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 7 days before study entry; Women who are not surgically sterilized or of childbearing age, 11. Use of a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period; And must be non-lactating; Men whose partner was a woman of reproductive age were advised to use an effective method of contraception for the duration of the trial and for 6 months after the last dose of treatment.
Exclusion criteria
Exclusion criteria: 1. Is participating in a clinical study and receiving treatment, or is participating in a study of another experimental drug within 4 weeks before starting a study drug, has received a study treatment, or has received a trial medical treatment, and has undergone a major surgical procedure within 4 weeks before randomization and has not recovered from any side effects from such procedures. 2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo. Children who had complete remission of asthma in childhood and did not need any intervention in adulthood could be included. Patients with asthma requiring medical intervention with bronchodilators were excluded). Replacement therapy was not considered systemic therapy, and patients with a history of autoimmune-related hypothyroidism who were receiving thyroid hormone replacement were eligible. Type I diabetes that can be controlled with insulin therapy. 3. Immunosuppressive, or systemic hormonal therapy for immunosuppression within 7 days before randomization (dose-> 10mg/ day prednisone or other effective hormones). 4. Any active malignancy within 5 years, except for the specific cancers under study in this trial and localized tumors that have been cured, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ. 5. Previous treatment with standard chemotherapy, such as XELOX (oxaliplatin + capecitabine), fuquinitinib; 6. Known history of central nervous system metastasis (if suspected, MRI scan is required to rule out) or hepatic encephalopathy; 7. A history of pneumonia (non-infectious) requiring steroid therapy within 6 months; 8. Patients with active infection, unexplained fever =38.5? within 7 days before medication, or baseline white blood cell count > 15×10 9 /L; Any serious acute or chronic infection requiring systemic antimicrobial, antifungal, or antiviral therapy (e.g., tuberculosis) at the time of screening, except for active hepatitis. 9. According to the investigator's judgment, patients have other factors that may affect the results of the study or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of patients. 10. Patients with congenital or acquired immune deficiency (such as HIV infection); 11. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) 12. Active hepatitis B is defined as a known positive result of HBsAg and HBV-DNA > 2000IU/ml. Active hepatitis C was defined as a known positive hepatitis C antibody with a quantitative HCV RNA result above the lower limit of detection of the analytical method. "For active hepatitis, subjects had HBV DNA < 500IU /mL (or 2500 copies /mL) at the time of screening." 13. Received a live attenuated vaccine within 4 weeks before randomization or was planned to require such vaccine during treatment with anti-PD-1 mab or within 5 months after the last dose; 14. The presence of more than a small amount of pericardial effusion, uncontrolled pleural effusion, or peritoneal effusion at screening was defined as the presence of a large amount of detectable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;R0 resection rate; | — |
Countries
China
Contacts
Public ContactMao Jie
Lan Zhou University Second Hospital
Outcome results
None listed