gastric cancer
Conditions
Interventions
Neoadjuvant therapy group:Preoperatively, they received a POLF regimen (paclitaxel 60 mg/m2, oxaliplatin 50 mg/m2, and 5-fluorouracil 425 mg/m2) administered once weekly for a total of 6 doses, in com
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent form prior to performing any trial-related processes; 2) Male or female, age = 18 years; 3) Histologically confirmed gastric adenocarcinoma with a diagnosis of locally progressive stage according to the AJCC 8th edition, a cTNM diagnosis of cT3-4aN1-3M0 according to ultrasonographic endoscopy or enhanced CT / MRI scans (combined with ultrasonographic gastroscopy and diagnostic laparoscopic exploratory surgery, if necessary), and a lesion that is assessed to be resectable by the investigator; 4) No prior systemic treatment for the current disease, including surgical treatment, antitumor radiotherapy/immunotherapy, etc; 5) Patients who agree to undergo radical surgical treatment and have no contraindications to surgery as determined by the surgeon; 6) ECOG score of 0-1; 7) Expected survival time > 6 months; 8) Adequate organ function, patients will be required to fulfill the following laboratory criteria: a) Absolute neutrophil count (ANC) = 1.0x109/L in the last 14 days without granulocyte colony-stimulating factor; b) Platelets = 80 x 109/L in the absence of blood transfusion in the last 14 days; c) Hemoglobin > 7 g/dL without transfusion or erythropoietin use in the last 14 days; d) Total bilirubin = 1.5 x upper limit of normal (ULN); enrollment is also allowed if total bilirubin > 1.5 x ULN but direct bilirubin = ULN; e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN. f) Blood creatinine = 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; g) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 x ULN; h) Normal thyroid function, defined as thyrotropin (TSH) within normal range. If baseline TSH is outside the normal range, patients may also be enrolled if FT4 is within the normal range; i) Cardiac enzyme profiles within the normal range (enrollment will be permitted if purely laboratory abnormalities are judged by the investigator to be of no clinical significance in the aggregate); 9) For female subjects of childbearing potential, a negative urine or serum pregnancy test should be obtained within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. A woman not of childbearing age is defined as being at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; 10) If there is a risk of conception, all subjects (either male or female) will be required to use contraception with an annual failure rate of less than 1% throughout the entire treatment period up to 120 days after the end-of-treatment administration of study drug (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1) Malignant disease other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2) Known endoscopy showing signs of active bleeding from the lesion; 3) Currently participating in an interventional clinical study treatment or have been treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose; 4) Prior therapy with: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitor of T-cell receptors (including, but not limited to, CTLA-4, OX-40, CD137, etc.); 5) Systemic therapy with proprietary Chinese medicines with antitumor indications or drugs with immunomodulatory effects (including thymidine, interferon, interleukin, except for topical use for the control of pleural fluid) within 2 weeks prior to the first dose; 6) Active autoimmune disease requiring systemic therapy (e.g., use of glucocorticoids or immunosuppressive agents, etc.) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy; 7) Being on systemic glucocorticoid therapy (excluding topical glucocorticosteroids by nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (=10 mg/day of prednisone or equivalent) are permitted; 8) Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9) Known hypersensitivity to the drugs used in this study. 10) Have not fully recovered from any intervention-induced toxicity and/or complications (i.e., = Grade 1 or at baseline, excluding malaise or alopecia) prior to initiation of treatment; 11) Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 12) Untreated active hepatitis B (defined as HBsAg positivity along with a detectable HBV-DNA copy number greater than the upper limit of normal in the Laboratory Department of the host research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: a) HBV viral load <1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the duration of study chemotherapeutic drug therapy to avoid reactivation of the virus b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed 13) Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 14) Live vaccination within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted within 30 days prior to the first dose; however, live attenuated influenza vaccine for intranasal administration is not permitted 15) Women who are pregnant or breastfeeding; 16) Presence of any serious or uncontrollable systemic disease, such as: a) Significant and symptomatic unmanageable abnormalities in rhythm, conduction or morphology on the resting ECG, such as complete left bundle br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete responses (pCR);main pathological responses (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);disease control rate (DCR);2-year PFS rate;3-year OS rate;safety; | — |
Countries
China
Contacts
Public ContactJie Liu
Institute of Digestive Diseases, Fudan University
Outcome results
None listed