Gastric cancer with liver metastasis
Conditions
Interventions
Experimental group:TACE+thermal ablation+apatinib +sintilimab +Oxaliplatin+Tegafur
Sponsors
Shandong First Medical University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent with good compliance and follow-up; 2. No gender limit, aged 18 -85 years; 3. ECOG score is 0-1; 4. Expected survival >= 3 months; 5. Patients with gastric cancer with liver metastasis confirmed by histopathology; 6. Clinical stage IV; 7. No previous systematic therapy, including chemotherapy, targeted therapy and immunotherapy; Note: Patients with recurrence more than 6 months after receiving neoadjuvant (radiotherapy) chemotherapy + radical surgery, patients with recurrence more than 6 months after the end of adjuvant (radiotherapy) chemotherapy or radical concurrent radiotherapy and chemotherapy; 8.No known positive HER-2; 9. At least 1 liver metastatic tumor must meet the following criteria: at least 1 liver metastatic tumor can be treated with 1 course of TACE and thermal ablation; 10. In addition to ablative lesions, there should be at least one measurable lesion in or outside the liver (tumor lesions with CT scan diameter >=10mm and lymph node lesions with CT scan diameter >=10mm according to RECIST 1.1 standards) (used to evaluate the distant effect); 11. The patient has recovered damage from other treatments, including other cytotoxic drugs, radiotherapy or surgery for >=4 weeks, and the wound has healed completely; 12. Patients should not have received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 13. Asymptomatic BMS or lesion control after radiotherapy for BMS; 14. Major organ function is normal, patient should meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony stimulating factor; (2) Platelets >=90x10^9/L without blood transfusion in the last 14 days; (3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or erythropoietin use; (4) No active bleeding, such as hematemesis, hematospermia, gingival bleeding, epistaxis and hemorrhoid bleeding, and fecal occult blood =60 ml/min; (8) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; Activated partial thrombin time (APTT) <=1.5xULN; (For patients receiving anticoagulant therapy, such as aspirin, warfarin, clopidogrel and other anticoagulant drugs, the drug should be stopped for at least 5-7 days in principle, and INR and APTT are judged by the researchers to be safe and effective treatment range); (9) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. patients with total T3 (or FT3) and FT4 within the normal range may be enrolled if baseline TSH is outside the normal range; (10) The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 15. Patients with potential fertility need to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for one month after the study treatment period ends; Serum or urine HCG tests must be negative within 72 hours prior to study entry and must be
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignancies that are not cured within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radical excision of carcinoma in situ); 2. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 3. The patient has any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Asthma in which patients require medical intervention with bronchodilators is not included); 4. Patients who were taking immunosuppressant, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; Note: Physiological doses of glucocorticoids (<=10 mg/ day of prednisone or equivalent) are permitted; 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Patients with known allergy to sindillizumab, apatinib, oxaliplatin and Ticeo; 7. Active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension within 30 days after major surgery; 8. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 9. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B patients who meet the following criteria may also be enrolled: (1) HBV viral load <1000 copies /ml (200 IU/ml) before initial dosing, patients should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapeutic treatment; (2) For patients with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required. 10. Active HCV-infected patients (HCV antibody positive and HCV-RNA level above the lower limit of detection); 11. Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not allowed. 12. The presence of any serious or uncontrolled systemic disease, such as: (1) The resting electrocardiogram has significant abnormal rhythm, conduction or morphology with serious symptoms and difficult to control, such as complete left bundle branch block, ? degree or above heart block, ventricular arrhythmia or atrial fibrillation; (2) The patients had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; (3) There was a history of non-infectious pneumonia requiring glucocorticoid therapy or clinically active interstitial lung disease within 1 year prior to initial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactSha Dan
Shandong First Medical University Affiliated Provincial Hospital
Outcome results
None listed