Adenocarcinoma of stomach/esophagogastric junction
Conditions
Interventions
test group:Vediximab: 2.5mg/kg, D1,ivdrip,Q3W
XELOX solution:
Oxaliplatin: 130mg/m2, intravenous infusion, administered on the first day, with one treatment cycle every 21 days
Capecitabine: 1000mg/m2, orally administered, Bid, d1-14, One treatment cycle every 21 days
Every 3 weeks is a treatment cycle until disease progression or intolerable toxicity occurs
Sponsors
Gansu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Age range: 18-75 years old, gender not limited; 2. Gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology as locally advanced and inoperable, or with distant metastasis; 3. HER-2 immunohistochemistry detection shows 2+or 3+; 4. Have at least one measurable lesion that meets the RECIST v1.1 criteria; 5. Have not received systemic treatment in previous stages of metastasis or recurrence, or have received neoadjuvant/adjuvant chemotherapy, but have experienced disease progression or recurrence for more than 6 months after the end of treatment; 6. ECOG PS: 0-1 point; 7. Adequate organ function: Bone marrow function: hemoglobin >= 80g/L; Neutrophil count >= 1.5 × 10^9/L; White blood cell count >= 3.5 × 10^9/L; Platelets >= 100 × 10^9/L; Liver function: Serum total bilirubin = 60 mL/min Cardiac function: NYHA classification= 50%. 8. Expected survival period >= 3 months; 9. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug. For males, they must agree to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug; 10. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Allergy to any investigational drug or its excipients, or a history of severe allergies, or contraindications to the investigational drug; 2. There are cardiovascular and cerebrovascular events that have not been well controlled, such as: a. NYHA grade 2 or above heart failure; b. Unstable angina pectoris; c. Have experienced myocardial infarction within one year; d. Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; e. Cerebral hemorrhage and infarction (excluding asymptomatic and untreated lacunar cerebral infarction); f. Serious cardiovascular and cerebrovascular events have occurred within the past 12 months; g. Uncontrollable hypertension, i.e. systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg after monotherapy; h. Patients with a history of arterial or deep vein thrombosis within the first 6 months of enrollment, or with evidence or history of bleeding tendency within the first 2 months of enrollment, regardless of severity; i. Stroke events or transient ischemic attacks occurred within the 12 months prior to enrollment; 3. Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti gastric cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control ascites); 4. Have a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 5. History of active immunodeficiency or autoimmune diseases, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or autoimmune diseases; 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. Patients with a history of active tuberculosis infection for >= 1 year prior to screening should also be excluded, unless proof can be provided that appropriate treatment has been completed; 7. There is brain metastasis or leptomeningeal metastasis; 8. Clinically significant pleural effusion, pericardial effusion, or ascites require multiple drainage attempts within 2 weeks prior to the first administration of the study drug; 9. There is a clinically detectable second primary malignant tumor at the time of enrollment, or other malignant tumors have appeared in the past 5 years (excluding fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. Have undergone any major surgical procedures <= 28 days prior to the first study drug administration; 11. Have undergone allogeneic stem cell transplantation or organ transplantation in the past; 12. Currently, there are digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; Or those who have a history of intestinal perforation or fistula and have not recovered after surgical treatment; 13. Have received a live vaccine within 4 weeks (inclusive) before the first use of the investigational drug; Seasonal flu vaccines are usually inactivated vaccines, so their use is allowed; Nasal vaccines belong to live vaccines, so their use is not allowed; 14. Acco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactDengwen Wei
Gansu Cancer Hospital
Outcome results
None listed