Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer (GC/GEJC)
Conditions
Interventions
Fruquintinib / Nab-paclitaxel:Fruquintinib / Nab-paclitaxel
Sponsors
Department of Medical Oncology, National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent form; 2. Age = 18 years; 3. Advanced gastric/gastroesophageal junction adenocarcinoma confirmed by pathology and experienced at least one systemic treatment; 4. The front line has experienced immune drug exposure (including PD-1 and PD-L1 drug exposure at the stage of neoadjuvant, adjuvant and systemic treatment; the patients who have metastasis and relapse within 6 months after the end of adjuvant/neoadjuvant system treatment, the above treatment is first-line treatment); 5. The physical condition of ECOG is 0-1 points and does not deteriorate within 7 days; 6. BMI=18; 7. Expected survival = 3 months; 8. The functions of important organs meet the following requirements (it is not allowed to use any blood components and cell growth factors within 14 days before enrollment): 1) Absolute neutrophil count = 1.5 × 109/L, white blood cell = 4.0 × 109/L 2) Platelet = 100 × 109/L 3) Hemoglobin = 90g/L; 4) Total bilirubin TBIL = 1.5 times ULN; 5) ALT and AST = 2.5 times ULN (liver metastasis patients can be relaxed to 5 times); 6) Urea/urea nitrogen (BUN) and creatinine (Cr) = 1.5 × ULN (and creatinine clearance rate (CCr) = 50mL/min) 7) Left ventricular ejection fraction (LVEF) = 50%; 8) The QT interval (QTcF) corrected by Fridericia method is less than 470 milliseconds; 9) INR=1.5 × ULNAPTT=1.5 × ULN 9. Women of childbearing age should take effective contraceptive measures; 10. Good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Failure to comply with the research protocol or research procedures; 2. Previous treatment with VEGFR inhibitor; 3. Previous paclitaxel treatment (except those who have received paclitaxel treatment in neoadjuvant or adjuvant therapy and the end time of treatment is more than 6 months from the progress of the disease); 4. HER-2 positive patients; 5. Receive live vaccine within 4 weeks before enrollment or possibly during the study period; 6. Other malignant tumors within 5 years before enrollment, except skin basal cell or squamous cell carcinoma after radical operation, or cervical carcinoma in situ; 7. Have active autoimmune diseases or have a history of autoimmune diseases within 4 weeks before enrollment; 8. Previously received allogeneic bone marrow transplantation or organ transplantation; 9. Subjects allergic to the study drug or any of its adjuvants; 10. Clinically significant electrolyte abnormalities judged by the researcher; 11. There was hypertension that could not be controlled by drugs before enrollment, which is specified as: systolic blood pressure = 150 mmHg and / or diastolic blood pressure = 90 mmHg; 12. Any disease or condition affecting drug absorption before enrollment, or the patient cannot take oral drugs; 13. Gastrointestinal diseases such as gastric and duodenal active ulcer and ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researcher before enrollment; 14. Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment (bleeding > 30 ml within 3 months with hematemesis, black stool and bloody stool), hemoptysis (fresh blood > 5 ml within 4 weeks) or thromboembolism events (including stroke events and / or transient ischemic attack) within 12 months; 15. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade > 2; Ventricular arrhythmias requiring drug treatment; LVEF (left ventricular ejection fraction) 1 × 104 copies / ml or > 2000 IU / ml); Hepatitis C virus infection (HCV) is known and HCV RNA is positive (> 1 × 103 copies / ml); 18. Higher than CTCAE V5 due to any previous anticancer treatment Unrelieved toxic reactions above grade 0.1, excluding hair loss, lymphopenia and neurotoxicity = grade 2 caused by oxaliplatin; 19. Pregnant (positive pregnancy test before medication) or lactating women; 20. Received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF) within 28 days before enrollment; 21. Any other disease, clinically significant metabolic abnormality,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival ; | — |
Countries
China
Contacts
Public ContactLin Yang
Department of Medical Oncology, National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Outcome results
None listed