Gastric cancer
Conditions
Interventions
Single arm:Drug therapy
Sponsors
Liaoning Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients voluntarily join this study and sign informed consent; 2. aged = 18 years, = 75 years; 3. pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. patients with clinical stage T3-4aN + M0 (according to AJCC 8th edition staging) who can be radically resected as determined by CT; 5. no anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. planned to receive surgical treatment after the completion of neoadjuvant therapy; 7. able to swallow tablets normally; 8. ECOG-PS score 0-1; 9. expected survival = 12 months; 10.Normal major organ function, that is, meeting the following criteria: (1) blood routine examination criteria need to meet: (14 days without blood transfusion and blood products, without G-CSF and other hematopoietic stimulating factors correction) absolute neutrophil count = 1.5 × 109/L; platelets = 80 × 109/L; hemoglobin = 80 g/L); (2) biochemical tests need to meet the following criteria: total bilirubin 50 ml/min (male: endogenous creatinine clearance rate = (((140-age) × body weight)/(72 × serum Cr); female: endogenous creatinine clearance rate = (((140-age) × body weight)/(72 × serum Cr) × 0.85; body weight unit kg; serum Cr unit: mg/mL); 11.Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose.Male subjects with partners of childbearing potential should be surgically sterilized or agree to use highly effective methods of contraception during the trial and for 120 days after the last dose;
Exclusion criteria
Exclusion criteria: 1. known HER2 positive; 2. allergic to fruquintinib, oxaliplatin, tegafur; 3. received anti-angiogenic small molecule TKI (regorafenib, apatinib, lenvatinib, anlotinib, etc.) drugs other than fruquintinib before enrollment; 4. used fruquintinib, oxaliplatin, tegafur before enrollment; 5. involved EGJ and tumor center located = 2 cm from EGJ proximal gastroesophageal junction cancer; 6. known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 7. there are unresectable factors, including unresectable tumor causes or surgical contraindications unresectable or refused surgery; 8. previous or simultaneous other malignant tumors, but cured skin basal cell carcinoma and cervical carcinoma in situ and breast cancer; 9. suffering from hypertension, hypertension, And can not be well controlled by antihypertensive drug treatment (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 10.Presence of any of the following cardiac clinical symptoms or diseases:.According to New York Heart Association (NYHA) criteria, heart failure greater than grade 2 or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 450 ms (male) or QTc > 470 ms (female) on resting state electrocardiogram;Abnormalities of great clinical significance (such as heart rate, conduction, morphological characteristics and other abnormalities) or complete left bundle branch block or tertiary heart block or secondary heart block or PR interval > 250 ms found by resting state ECG examination;Presence of factors that increase the risk of QTc prolongation, heart rate abnormalities such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in an immediate family member under 40 years of age, or concomitant medication that prolongs the QT interval. 11.Previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging, clinical symptoms suggestive of intestinal obstruction; 12.Abnormal coagulation function (INR > 2.0 or prothrombin time (PT) > 16s), bleeding; tendency or receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed); 13.Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis, etc.; if stool occult blood is positive at baseline, they can be reexamined; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients receiving gastroscopy within 3 months before enrollment to exclude such conditions); 14.Arterial/venous thrombotic events within 6 months before randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 15.Known hereditary or acquired bleeding and thrombophilia (e.g., hemophilia, coagulopathy, thrombocytopenia, etc.); 16.Accompanied by active ulcer, unhealed wound or fracture; 17.Urine routine showed urine protein = + + and confirmed 24-hour urine protein > 1.0 g; 18.Patients in the active stage of infection need antimicrobial therapy (such as antibacterial drugs, antiviral drugs, antifungal d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;R0 resection rate;Event-free survival;Overall survival; | — |
Countries
CHINA
Contacts
Public ContactXiangyu Meng
Liaoning Cancer Hospital
Outcome results
None listed