Advanced gastric cancer
Conditions
Interventions
Experimental group: anlotinib combined with albumin bound paclitaxel
Sponsors
Chizhou people's Hospital, Anhui Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patient informed consent to participate in the study. 2) The patient was diagnosed with stage IV gastric adenocarcinoma through biopsy/pathological examination (any T, N, M1, extragastric measurable lesion [RECIST 1.1 standard], including locally advanced tumors that cannot be resected, advanced tumors that have undergone R1 or R2 resection, as well as recurrence or metastasis status after R0 resection, and progression after first-line chemotherapy or chemotherapy combined with immune and targeted systemic therapy. 3) The patient is over 18 years old, and the performance status score of the Eastern Cancer Collaborative Group is 0-2 points. 4) The main organ functions meet the following criteria within 7 days before treatment: routine examination criteria (no blood transfusion within 14 days): hemoglobin = 90g/L, absolute neutrophil count = 1.5 × 109/L, platelet count (PLT) = 80 × 109/L; Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5xULN, or if liver metastasis occurs, ALT and AST = 5xULN, serum creatinine = 1.5xULN, or creatinine clearance rate = 60mL/min. 5) Women of childbearing age agree to use contraceptives (such as intrauterine devices, contraceptives, or condoms) during the study period and the first 6 months after the study; A negative serum or urine pregnancy test was conducted 7 days prior to study registration, and the patient was not lactating. The male candidate agrees to use contraceptive measures during the study period and the first 6 months after the study.
Exclusion criteria
Exclusion criteria: 1) Patients who have previously been treated with anlotinib and paclitaxel. 2) Patients who have previously received treatment with VEGFR tyrosine kinase inhibitors, such as sunitinib, sorafenib, fanitinib, apatinib, and regafenib. 3) Patients who currently or previously have other malignant tumors, except for cervical cancer in situ, non melanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Ti [in situ cancer], and T1) (tumor infiltrating basement membrane). 4) The patient received systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, 4 weeks prior to enrollment or during the study period. 5) Toxic effects that have not been resolved due to adverse reactions caused by previous treatment. Common Terminology Standards (CTCAE) (4.0) 6) Patients with any signs of bleeding or medical history, regardless of severity, with bleeding or bleeding events = CTCAE level 3 within 4 weeks prior to registration; Or unhealed wounds, ulcers, or fractures. Patients with a significant possibility of gastrointestinal bleeding, including local active ulcer lesions and fecal occult blood 2+; Patients with a history of melanoma, vomiting blood, and fecal occult blood in the past 2 months, as well as patients with primary gastric tumor lesions that have not been surgically removed, are considered to have a high risk of gastrointestinal bleeding by the main researchers. 7) Medical conditions that affect the ability to take oral medication (such as inability to swallow, chronic diarrhea). 8) Patients with respiratory symptoms caused by pleural effusion or ascites (= CTCAE2 grade dyspnea (grade 2 dyspnea refers to shortness of breath during low-intensity physical activities that affect daily life). 9) Severe and/or uncontrolled disease in patients with any of the following conditions: taking an antihypertensive medication but still having unsatisfactory blood pressure (systolic blood pressure = 150mm Hg, diastolic blood pressure = 100mm Hg); According to the classification of the New York Heart Association, patients with grade 1 or above myocardial ischemia or myocardial infarction, malignant arrhythmias (including QTC = 480ms), and = grade 2 congestive heart failure; Severe infections that are effective or uncontrollable (= CTCAE2 level infection); Cirrhosis, decompensated liver disease or active hepatitis; Renal failure requiring hemodialysis or peritoneal dialysis; History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency, or history of organ transplantation; Poor control of diabetes (fasting blood glucose [FBG]>10mmol/L); Urine analysis showed that urine protein was =++and confirmed to be>1.0g 24-hour urine protein; Epilepsy requires treatment; A history of psychiatric drug abuse and inability to quit smoking; Mental disorders; Brain metastasis with neurological symptoms or symptom control less than 2 months. 10) Patients who have undergone major surgical treatment, open biopsy, or significant trauma within 28 days prior to enrollment. 11) Arterial/venous thrombosis causes events that occur within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism. 12) Patients who participate in clinical trials of other anti-tumor drugs or undergo other clinical trials within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable tumor focus;PFS,; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;ORR;DCR; | — |
Countries
china
Contacts
Public ContactXu Jinfa
Chizhou people's Hospital, Anhui Province
Outcome results
None listed