Gastric cancer
Conditions
Interventions
Experimental group:Apatinib+Chematherapy
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years. 2. The ECOG score is 0-1. 3. Patients with advanced gastric cancer who have previously undergone gastrectomy and second-line therapy for recurrence and metastasis. 4. The patient failed systemic therapy after surgery, and the definition of therapy failure: disease progression during the treatment process or recurrence after the end of treatment, intolerable toxicity and side effects). Note: (1) Each line of treatment for advanced disease includes one or more drugs for >=1 cycle. (2) Adjuvant/neoadjuvant therapy is allowed in the early stage. Adjuvant/neoadjuvant therapy was considered a first-line upfront systemic chemotherapy for advanced disease if relapse occurred during or within = 3 months. 6. The patient's baseline blood routine and biochemical indicators meet the following criteria: white blood cell count >=3500/mm^3; hemoglobin >=9.0 g/dL; absolute neutrophil count (ANC) >=1,500/mm^3; platelet count >=100,000/mm^3; total Bilirubin <=1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase <=2.5 ULN; prothrombin time international normalized ratio <=1.5, and partial thromboplastin time within the normal range (1.2 times the lower limit of normal to 1.2 times the upper limit of normal); creatinine <= 1.5 ULN. 7. Patients informed and agreed to participate in the research.
Exclusion criteria
Exclusion criteria: 1. Patients with severe hypertension and poor drug control in the past; 2. Difficulties in taking oral medicines due to dysphagia, complete or incomplete gastrointestinal obstruction, active bleeding in the gastrointestinal tract, perforation, etc.; 3. Those who are known to be allergic to taxanes, or have metabolic disorders; 4. Received anti-vascular targeted therapy in the past, such as ramucirumab and apatinib; 5. At the same time participating in other cancer trial drugs or in other cancer clinical trials; 6. Severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease, or uncontrolled diabetes, hypertension and other chronic system diseases; heart disease with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia that is difficult to control by drugs, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency; 7. Those with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders; 8. Clinically serious infection of >CTCAE (version 5.0) grade 2 in active stage; 9. Patients with other cancers than gastric cancer within five years of the start of treatment in this study, excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumors [including Ta and Tis]; 10. Women who are pregnant, breastfeeding, women of childbearing age and their spouses refuse to take effective contraceptive methods; 11. Those who have no legal capacity, and those whose medical or ethical reasons affect the continuation of research; 12. The investigator determines other circumstances that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS);Maximal tolerable dose(MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate(ORR);Disease control rate(DCR);Duration of remission(DOR);Overall survival(OS); | — |
Countries
China
Contacts
Public ContactLuo Tianhang
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed