Locally advanced resectable adenocarcinoma of the gastroesophageal junction/gastric region
Conditions
Interventions
B group: SOX and sintilimab:SOX and sintilimab
A group: fruquintinib plus SOX and sintilimab:SOX+ fuquinitinib + sintilimab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. Diagnosed with adenocarcinoma through pathological histological examination. The imaging examination is based on the 8th edition of AJCC staging and is classified as cT3-4aN0-3M0. The patient is assessed as being operable for surgery. Gastric/gastroesophageal junction (GEJ) cancer only allows Siewert type III patients, as well as Siewert type II patients who do not require combined thoracotomy for inclusion; 3. No previous anti-tumor treatment; 4. Agree to provide tissue examination specimens at baseline and during surgery (for detecting PD-L1 expression, tumor mutation burden, and infiltration lymphocyte status, etc.); 5. ECOG PS score = 6 months; 7. Good liver and kidney function and bone marrow function. The sample must be collected within 10 days before the start of treatment. Laboratory test standards are as follows: Total bilirubin = 60 mL/min; Serum albumin >= 30 g/L (3.0 g/dL); Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) are all = 75,000 /mm^3; Hemoglobin >= 9 g/dL; Neutrophil count >= 1500/mm^3; 8. For female subjects: Should be post-surgical sterilized, post-menopausal patients, or agree to adopt a medically approved contraceptive measure (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 6 months after the study treatment period; Blood pregnancy test must be negative within 7 days before the administration of study medication, and must be non-lactating. For male subjects: Should be post-surgical sterilized, or agree to adopt a medically approved contraceptive measure during the study treatment and within 6 months after the study treatment period; 9. Voluntarily participate and sign the informed consent form, willing to follow and be capable of completing all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Samples were confirmed as dMMR by histopathology and immunohistochemistry or MSI-H by genetic testing; Live vaccines include but are not limited to the following vaccines: measles, mumps, rubella, chickenpox/zoster (varicella), yellow fever, rabies, BCG (bacillus Calmette-Guérin), and typhoid vaccine. Seasonal influenza injection vaccines are usually inactivated virus vaccines, therefore allowed to use; however, nasal influenza vaccine (such as FluMist®) is a live attenuated vaccine, therefore not allowed to use.2. Previous systemic or local treatment for gastric cancer; 3. Stage IV (metastatic) or investigator-determined inoperable gastric/gastroesophageal junction adenocarcinoma; Other active malignancies within 4.5 years or at the same time. Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled. 5. Patients who are preparing for or have previously received organ (including corneal transplantation) or bone marrow transplantation; (6) Myocardial infarction with uncontrolled arrhythmia (QTc interval >= 450 ms in men and >= 470 ms in women) within 6 months before randomization (QTc interval calculated with Fridericia's formula); 7. Presence of NYHA standard ?-? cardiac dysfunction or echocardiography: LVEF 10 mg/ day prednisone efficacy dose) or other immunosuppressive agents within 14 days before randomization or during the study. Patients were allowed, however, to receive adrenal-hormone replacement therapy with topical or inhaled steroids or at a therapeutic dose of less than =10mg per day of prednisone in the absence of active autoimmune disease. 14. Any active infection requiring systemic anti-infective treatment within 14 days before randomization; Exclusions include receiving prophylactic antibiotics (e.g., to prevent urinary tract infections or chronic obstructive pulmonary disease); 15. Previous antibody/drug therapy against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc. 16. Is receiving treatment in another study or is scheduled to start treatment in a study less than 28 days after the end of treatment in a previous study; Note: Participants who were already in the follow-up phase of the study could participate as long as it had been more than 4 weeks since the last dose was administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Survival period;R0 resection rate;Event-free survival;Safety;Biomarkers;Major pathological response rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactKun Yang
West China Hospital of Sichuan University
Outcome results
None listed