Advanced gastric cancer
Conditions
Interventions
Case series:apatinib
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years; 2. Gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma sig, poorly differentiated adenocarcinoma por) confirmed by pathology (including histology or cytology) is an unresectable locally advanced or metastatic (stage IV) tumor; 3. For patients with advanced gastric cancer who had received standard first-line treatment in the past, the interval of the last chemotherapy should be more than 1 month; 4. Has not previously accepted treatment regimens containing echinoside drugs, apatinib mesylate or other anti-angiogenic drugs; 5. According to RECIST1.1 standard, the patient had at least one target lesion with measurable diameter (tumor lesion CT scan length >=10mm, lymph node lesion CT scan short diameter >=15mm, scan thickness 5mm); 6. ECOG performance status (PS) 0 - 2; 7. Life expectancy of at least 3 months; 8. The damage caused by subjects receiving other treatments has recovered, including receiving nitroso or mitomycin at intervals >=6 weeks; Received other cytotoxic drugs, radiotherapy or surgery >=4 weeks, and the wound had completely healed; 9. Patients with adequate organ function at the time of enrollment as defined below: (1) Blood routine examination standard (without blood transfusion within 14 days before enrollment): HB >=90g/L; WBC >=3.5x10^9/L; ANC >=1.5x10^9/L; PLT >=75x10^9/L; (2) Biochemical examination shall meet the following standards: BIL 50ml/min (Cockcroft-Gault math); 10. Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patientsand agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period; 11. Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Exclusion criteria
Exclusion criteria: 1. Patients with chemotherapy and apatinib mesylate contraindication; 2. A woman who is pregnant or nursing; 3. Chemotherapy drugs, targeted drugs and immunotherapy were used within 1 month before enrollment. Who participated in other clinical studies within 1 month before enrollment and did not recover toxic reactions; 4. Previous or coexisting malignancies, with the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ; 5. Accompanied by serious heart, liver, kidney disease; Symptomatic brain metastases are not controlled; Neurological and mental diseases; Accompanied by severe infection, jaundice and obstruction of the digestive tract; 6. Patients with hypertension that cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 7. Patients with grade I or above coronary heart disease, arrhythmia (including prolonged QTc interval >450 ms for men and > 470 ms for women) and cardiac insufficiency; 8. Patients with a clear tendency to gastrointestinal bleeding include: local active ulcer lesions, fecal occult blood (++), and a history of black stool or hematemesis within 2 months; Abnormal coagulation function (INR>1.5, APTT>1.5 ULN); 9. Patients with a previous history of cardiovascular and cerebrovascular diseases who are still taking oral thrombolytic drugs or anticoagulants; 10. Patients with positive urine protein (urine protein test 2+ or above, or 24-hour urine protein quantitative >1.0g); 11. According to the judgment of the researcher, patients with other serious risks to patient safety or concomitant diseases that affect the completion of the study; 12. A variety of factors that affect oral medications (such as inability to swallow, persistent uncontrolled nausea and vomiting, chronic diarrhea, and intestinal obstruction); 13. Allergic to experimental drugs or their excipients; 14. The researchers concluded that the participants were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Countries
China
Contacts
Public ContactFeng Ye
The First Affiliated Hospital of Xiamen University
Outcome results
None listed