gastric adenocarcinoma
Conditions
Interventions
treatment:capecitabine + oxaliplatin + PD-1 inhibitor + oral Impact
control:capecitabine + oxaliplatin
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18-75 years old, male or female; (2) Pathologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma that has not received antitumor therapy. Only Siewert type III and Siewert type II subjects who do not require combined thorotomy are admitted for GEJ cancer. (3) Clinical staging: chest and abdominal enhanced CT was used for clinical staging, and endoscopic ultrasound, contrast-enhanced ultrasound, MRI or PET-CT were performed if necessary. For non-esophagogastric junction tumor: cT3-4aN1-3M0, for GEJ tumor cT1-2N1-3M0, cT3-4aN0-3M0 (AJCC, 8th Edition, 2017); (4) Eastern Cooperative Oncology Group (ECOG) score 0-1; (5) Adequate organ function: a) Blood routine (no transfusion, no use of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to treatment, no corrected with other drugs) : Neutrophil count (NE) >1.5×10^9/µL; Hemoglobin count (HGB) >90 g/L; Platelet count (PLT) >100×10^9/L. b) Blood biochemistry (liver and kidney function) : serum creatinine (Cr) = 1.5× upper limit of normal, ULN) or creatinine clearance =50ml/min; Total bilirubin (TBIL) = 1.5×ULN; Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) level =2.5 x ULN. (7) The subjects voluntarily join the study, signed the informed consent, have good compliance, and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients who have received any of the following medical interventions in the 4 weeks prior to treatment: a) drug therapy participating in other clinical studies; b) History of live attenuated vaccine. (2) Previously received monoclonal antibodies of Programmed death-1 (PD-1) /PD-1 ligand (PD-L1), cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or other immune or molecular targeted therapy; (3) Patients who cannot eat at all; (4) There is already perforation of the digestive tract or high risk of perforation; (5) The investigator judged that surgery could not be tolerated; (6) Patients with interstitial pneumonia, non-infectious pneumonia or pulmonary fibrosis; (7) Patients receiving long-term systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any form of immunosuppressive therapy within 14 days prior to the first administration of the study drug; (8) The presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; (9) An active infection prior to treatment (such as the need for intravenous antibiotics, antifungal or antiviral drugs), or an unexplained fever >38.5°C during screening/prior to initial dosing; (10) Metal implants or foreign bodies in the body (including but not limited to pacemakers, nerve stimulators); (11) Patients with other active malignant tumors within 5 years or at the same time, cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., could be included; (12) Known to be allergic to the investigational drug or any of its excipients, or to have had a severe allergic reaction to other monoclonal antibodies; (13) Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures; (14) In the investigator's judgment, there is a concomitant disease that seriously endangers the safety of the subject, may confuse the study results, or may interfere with the subject's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of R0 resection;Status of Lymph Nodes after neoadjuvant therapy;adverse event;Treatment tolerance; | — |
Countries
China
Contacts
Public ContactXiaodong Chen
Sichuan Cancer Hospital
Outcome results
None listed