gastric cancer
Conditions
Interventions
experimental group:Fruquintinib Capsules:4 mg / day, orally once daily on days 1-14 in 21-day cycles. If the patient has AE of grade 3 or above, the dose of fruquintinib capsules is reduced to 3 mg /
Sponsors
ZhongShan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years ; 2. Histologically confirmed advanced gastric cancer. The first-line systemic treatment containing oxaliplatin and fluorouracil failed. According to RECIST version 1.1, there is at least one measurable lesion; 3. Eastern Cooperative Oncology Group(ECOG)score 0 or 1 ; 4.Expected survival >= 12 weeks ; 5.Adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 1 week before the first drug treatment ): (1) Blood routine: leucocyte >=3.0×109/L, absolute neutrophil count (ANC) >=1.5 ×109/L, platelet count(PLT) >= 100×109/L, Hemoglobin ( Hb ) >= 9.0 g/dL; (2)Liver function : total bilirubin 50 % detected by two-dimensional echocardiography. 6.Understand the research and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients have received clinical trials of other research drugs or research instruments within 28 days before the first study of treatment ;or received anti-tumor treatment including but not limited chemotherapy, radiotherapy (excluding palliative radiotherapy completed at least 1 week before the treatment )and targeted therapy within 2 weeks before the first study of treatment; 2.The toxicity of previous anti-tumor therapy has not returned to the level of 0 or 1 (excluding alopecia , peripheral neurotoxicity caused by chemotherapy = 104copies / ml or > 2000IU / ml in the screening period ; 9.Cardiovascular diseases with significant clinical significance, including but not limited acute myocardial infarction, severe / unstable angina, cerebrovascular accident or transient ischemic attack, congestive heart failure (New York Heart Association classification > 2) within 6 months before enrollment;other arrhythmia treated with drugs(exclude ß blockers or digoxin); electrocardiogram repeated detection of QTcF interval >= 450 ms.; hypertension failed to be well controlled after antihypertensive drug treatment (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg ). 10.Clinically significant abnormalities in serum electrolyte levels ; 11.Women during pregnancy or lactation ; 12.Fertile but unwilling to accept effective contraception ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-Treatment Failure;Objective Response Rate;Overall survival;Time to progression;Duration of response;Disease control rate; | — |
Countries
China
Contacts
Public ContactLiu Tianshu
ZhongShan Hospital Fudan University
Outcome results
None listed