Gastric Cancer
Conditions
Interventions
Single Arm:Utidelone in combination with tegio, anlotinib and sintilimab
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Informed Consent: Fully understands the study and voluntarily signs the informed consent form. 2.Age: 18-80 years old (inclusive), male or female. 3.Diagnosis: Histologically or pathologically confirmed unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. 4.Performance Status: ECOG performance status 0-1. 5.Life Expectancy: Estimated survival >=3 months. 6.Prior Therapy:No prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease (including chemotherapy, targeted therapy, immunotherapy, etc.).If received adjuvant therapy after radical gastrectomy, must have >6 months between last adjuvant treatment and diagnosis of metastatic disease. 7.Measurable Lesion: At least one measurable lesion per RECIST v1.1 criteria. 8.Organ Function Requirements (no blood products or growth factors within 14 days prior to enrollment): Absolute neutrophil count (ANC) >=1.5×10^9/L, white blood cells >=3.0×10^9/L Platelets >=90×10^9/L Hemoglobin >=8 g/dL Total bilirubin (TBIL) =50 mL/min) Left ventricular ejection fraction (LVEF) >=50% QTcF interval <470 ms INR <=1.5×ULN, APTT <=1.5×ULN Thyroid function: TSH <=ULN (if abnormal, FT3 and FT4 must be normal) 9.Pregnancy Test: Negative serum or urine pregnancy test required for premenopausal women and women <1 year postmenopausal.
Exclusion criteria
Exclusion criteria: 1. Patients with known HER-2 positive status (immunohistochemistry 3+, or, immunohistochemistry 2+&FISH positive); 2. Other malignant tumors within 5 years prior to enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix; 3. Previous allogeneic bone marrow transplantation or organ transplantation; 4. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, within 6 months prior to enrollment; 5. Subjects who are allergic to the study drug or any of its auxiliary preparations; 6. Presence of hypertension uncontrolled by medication prior to enrollment, prescribed: systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 90 mmHg; 7. Have any disease or state that affects the absorption of the drug before enrollment, or the patient cannot take the drug orally; 8. Active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases or unresected tumors with active bleeding before enrollment, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; 9. Patients with evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL within 3 months, with hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 10. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) grade > 2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) = CTCAE v5.0 grade 2 infection); 12. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positivity (>1×10^4 copies/mL or >2000 IU/ml); Known hepatitis C virus infection (HCV) with HCV RNA positive (>1×10^3 copies/mL); 13. Patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patient has vitiligo; Asthma that has been completely resolved in childhood and does not require any intervention in adulthood may be included; Asthma in patients requiring medical intervention with bronchodilators could not be included); Replacement therapy is not considered systemic therapy, and the following patients may be enrolled: those with a history of autoimmune-related hypothyroidism who have received thyroid hormone replacement therapy; Type 1 diabetes that can be controlled with insulin therapy. 14. Use of immunosuppressants, or systemic hormone therapy within 7 days prior to enrollment to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other efficacy hormones). 15. Current interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, radiation pneumonitis; 16. Females who are pregnant (positive pregnancy test before medication) or breastfeeding; 17. Any other disease, clinically s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactKe Liu
Shanghai Changzheng Hospital
Outcome results
None listed