Gastric Cancer
Conditions
Interventions
Case series:Anlotinib Combined with SOX Regimen
Sponsors
Gang Ji
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients provided written informed consent form to participate in the study; 2. Patients were diagnosed with stage IV gastric adenocarcinoma by biopsy/pathology (any T, N, M1, with extra-gastric measurable lesions [RECIST 1.1 criteria] including unresectable locally advanced tumors, advanced tumors by R1 or R2 resection, and recurrence or metastasis status post R0 resection; 3. Patients aged 18 years or older with an Eastern Cooperative Oncology Group performance status score of 0 to 2 points; 4. Functions of the major organs met the following criteria within 7 days before treatment: routine examination standard (without blood transfusion within 14 days): hemoglobin >=90g/L, absolute neutrophil count >=1.5x10^9/L, platelet (PLT) >=80x10^9/L; and chemistry panel test met the following criteria: total bilirubin (TBIL) =60mL/min; 5. Women of childbearing age agreed to use contraceptives (e.g., intrauterine devices, contraceptives, or condoms) during the study period and within the first 6 months after the study; had a negative serum or urine pregnancy test 7 days prior to study enrollment, and were non-lactating patients. Male candidates agreed to use contraception during the study period and within the first 6 months after the study.
Exclusion criteria
Exclusion criteria: 1. Patients who were previously treated with anlotinib; 2. Patients who were previously treated with VEGFR-tyrosine kinase inhibitors such as sunitinib, sorafenib, famitinib, apatinib, and regorafenib; 3. Patients currently suffering from or who previously had other malignant tumors within 5 years, except cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Tis [in situ carcinoma] and T1 (tumor-infiltrating basement membrane]); 4. Patients received systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors, and immunotherapy 4 weeks prior to enrollment or during the study or who were treated with mitomycin C in the 6 weeks before study. Patients received extended-filed radiation therapy in the 4 weeks before enrollment or involved field radiation therapy in the 2 weeks prior to enrollment; 5. Patients with unresolved toxic effects above Grade 1 Common Terminology Criteria for Adverse Events(CTCAE) (4.0) due to prior treatment, but not including alopecia and oxaliplatin-induced neurotoxicity that was lower than Grade two; 6. Patients with any sign or history of hemorrhage, regardless of severity, with any bleeding or bleeding episodes >= CTCAE Grade 3 within 4 weeks prior to enrollment; or with unhealed wounds, ulcers, or fractures. Patients with a clear possibility of gastrointestinal bleeding, including the following conditions: local active ulcer lesions, and fecal occult blood 2+; patients with a history of melanoma, hematemesis, fecal occult blood 1+ in the past 2 months, and patients with gastric tumor primary lesions without surgically resection, and considered to be at high risk of having gastrointestinal bleeding by main research staff; 7. Medical conditions that affected ability to take oral medication (e.g., inability to swallow, chronic diarrhea); 8. Patients with pleural effusion or ascites, causing respiratory symptoms (>=CTCAE Grade 2 dyspnea (level 2 dyspnea refers to shortness of breath during low-intensity physical activity, affecting instrumental activities of daily living); 9. Patients with any of the following severe and/or uncontrolled diseases: taking one antihypertensive medication but still having unsatisfactory blood pressure (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); suffering from Grade 1 or above myocardial ischemia or myocardial infarction, malignant arrhythmia (including QTC >= 480ms) and >=Grade 2 congestive heart failure according to New York Heart Association classification; active or uncontrolled severe infection (>=CTCAE Grade 2 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 diseases, or a history of organ transplantation; poorly controlled diabetes (fasting blood glucose [FBG] >10mmol/L); urinalysis indicating urine protein >=++ and confirmed >1.0 gof 24-h urine protein; seizures that require treatment; history of psychotic medication abuse and are unable to quit; mental disorder; brain metastases with neurological symptoms or symptoms controlled for less than 2 months; 10. Patients who had major surgical treatment, open biopsy, or significant traumatic injury within 28 days before enrollment; 11. Arterial/venous thrombosis caused events that occurred within 6 months such as cerebrovascular accid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;disease control rate;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety indicator; | — |
Countries
China
Contacts
Public ContactGang Ji
Xijing Hospital, The Fourth Military Medical University
Outcome results
None listed