gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Control group:Camrelizumab combined with apatinib and SOX
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the study and sign the informed consent form; 2. Age >= 18 years; 3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Clinically staged at T3-4aN+M0 (according to AJCC 8th edition of staging) with potential for curative resection as confirmed by CT or MRI; 5. No prior anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy); 6. Planned surgery after completion of neoadjuvant therapy; 7. Ability to swallow pills normally; 8. ECOG-PS score 0-1; 9. Expected survival >= 12 months; 10. Main organs function normally, i.e., the following criteria are met: (1) For hematology tests: (No transfusion of blood or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors) • Absolute neutrophil count >= 1.5 * 10^9/L. • Platelets >= 80 * 10^9/L; • Hemoglobin = 80 g/L (2) For blood chemistry tests: • Total bilirubin 50 mL/min (for males: creatinine clearance rate = ((140 - age) * weight)/(72 * serum Cr); for females: creatinine clearance rate = ((140 - age) * weight)/(72 * serum Cr) * 0.85; weight unit: kg; serum Cr unit: mg/mL). 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer. Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.
Exclusion criteria
Exclusion criteria: 1. Known HER2 positive; 2. Gastroesophageal junction cancer involving the EGJ and with the tumor center located at the proximal end of the stomach = 2cm from the EGJ; 3. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4. Presence of unresectable factors, including unresectable tumor, surgical contraindications, and refusal of surgery; 5. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Hypertension that cannot be well controlled with antihypertensives (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 7. Presence of any of the following cardiac clinical symptoms or diseases: • Grade 2 or higher heart failure according to New York Heart Association (NYHA) or color Doppler echocardiography: Left ventricular ejection fraction (LVEF) 450 ms (males) or QTc > 470 ms (females) by resting electrocardiogram (ECG) examination; • Important clinically significant abnormalities (such as abnormalities in heart rate, conduction, and morphological features) or complete left bundle branch block or third-degree heart block or second-degree heart block or PR interval > 250 ms on resting ECG; • Presence of factors that increase the risk of QTc prolongation or abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in an immediate family member under 40 years of age, or any concomitant medications that prolong the QT interval; 8. History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) occurrence of intestinal obstruction, or concurrent intestinal obstruction indicated by imaging or clinical symptoms; 9. Patients with abnormal coagulation function (international normalized ratio (INR) > 2.0 or prothrombin time (PT) > 16s), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low molecular weight heparin is allowed); 10. Clinically significant hemorrhage symptoms or a clear hemorrhage tendency within 3 months prior to randomization, such as hemorrhage of digestive tract, ulcer stomach with hemorrhage, and vasculitis. Patients who are positive for fecal occult blood at baseline can be retested, and gastroscopy is required if the result of retesting is still positive (except for those who have undergone gastroscopy within 3 months prior to enrollment to rule out such condition); 11. Arterial/venous thrombotic events within 6 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attack, hemorrhage brain, and cerebral infarction), deep vein thrombosis, and pulmonary embolism; 12. Known inherited or acquired hemorrhage and thrombophilia (such as hemophilia, coagulation disorders, and platelets decreased); 13. With active ulcers, unhealed wounds, or fractures; 14. Urine protein = ++ indicated by urinalysis and confirmed 24-hour urine protein quantitation > 1.0 g; 15. Active infection requiring antimicrobial therapy (such as antibacterial, antiviral, and antifungal drugs); 16. Active hepatitis (reference for hepatitis B: HBsAg positive and HBV DNA = 500 IU/mL; reference for hepatitis C: HCV antibody positive and HCV virus copies > upper limit of normal (ULN)); 17. Cong
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;ypN staging;Event free survival (EFS);Disease-free survival (DFS);Overall survival(OS);Safety;Major pathological response (MPR);total Pathologic complete response (tpCR); | — |
Countries
China
Contacts
Public ContactZhenggang Zhu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed