A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
NCT ID: NCT03271073
Last Updated: 2017-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2016-02-01
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apatinib plus S1
patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity
Apatinib
Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
Interventions
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Apatinib
Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;
4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10\*9/L, neutrophil ≥1.5 × 10\*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
6. Expected survival of ≥ 12 weeks.
Exclusion Criteria
2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
3. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
7. Associated with CNS (central nervous system) metastases;
8. Active bacterial infections;
9. Pregnant or breast-feeding women;
10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhongtao Zhang
assistant dean, professor
Principal Investigators
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Wei Deng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHEAD-Y001
Identifier Type: -
Identifier Source: org_study_id
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