gastric carcinoma
Conditions
Interventions
Group 1 :trifluridine tipiracil (TAS-102) combined with oxaliplatin
Sponsors
Fujian Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before implementing any trial-related procedures, sign a written informed consent; 2. Age >= 18 years old, = 10 mm, short diameter of CT scan of lymph node lesions >= 15 mm, and scan slice thickness 5 mm); 5. No previous surgical treatment, no anti-tumor radiotherapy/chemotherapy/immunotherapy; 6. Preoperative laparoscopic examination confirmed no peritoneal implant metastasis and positive exfoliated cells; 7. ECOG score 0-1; 8. Expected survival time > 6 months; 9. Sufficient organ function, the subject needs to meet the following laboratory indicators: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without using granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >= 100 x 10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin in the past 14 days; (4) Total bilirubin ULN but direct bilirubin = 60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range (for example, subjects with baseline TSH exceeding the normal range, but total T3 (or FT3) and FT4 within the normal range can also be enrolled); (9) Myocardial enzyme spectrum is within the normal range (such as simple laboratory abnormalities that are judged by the investigator to have no clinical significance are also allowed to enter the group); 10. For female subjects of childbearing age, they should receive a urine or serum pregnancy test within 3 days before receiving the first study drug administration (1st cycle, 1st day) and the result is negative. If the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test will be ordered. Women of non-reproductive age are defined as postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; if there is a risk of conception, all subjects (regardless of male or female) need to be administered throughout the treatment period until the end of treatment Use contraceptive measures with an annual failure rate of less than 1% within the next 120 days (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than gastric cancer within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically resected carcinoma in situ); 2. Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. If the stool occult blood is positive during the baseline period, reexamination can be performed , if it is still positive after the re-examination, a gastroscopy is required (except for those who have undergone gastroscopy within 3 months before enrollment to exclude such cases); 3. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration; 4. Received systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the ingredients or excipients of this clinical research drug; 8. Those with multiple factors that affect TAS-102 (such as inability to swallow and intestinal obstruction); 9. Has not fully recovered from toxicity and/or complications caused by any intervention (ie, <= grade 1 or reached baseline, excluding fatigue or alopecia) before starting treatment; 10. Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive and detection of HBV-DNA copy number greater than the upper limit of normal value of the laboratory laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: (1) The HBV viral load before the first administration is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation; (2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), it is not necessary to receive prophylactic anti-HBV treatment, but close monitoring of viral reactivation is required. The test subject has an immunodeficiency disease or medical history, or has a history of organ transplantation; 12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 13. Received live vaccine within 30 days before the first dose (cycle 1, day 1) (Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; but intranasal administration is not allowed live attenuated influenza vaccine); 14. Pregnant or lactating women; 15. Patients with a clear tendency of gastrointestinal bleeding, including the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Regression Grade 0/1 (TRG 0/1);Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Incidence of Severe Adverse Events;Disease control rate;R0 resection rate;Overall Survival (OS) ;Disease-free survival (DFS) ; | — |
Countries
China
Contacts
Public ContactChen Yigui
Fujian Tumor Hospital
Outcome results
None listed