Status:
UNKNOWN
A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate ...
Eligibility Criteria
Inclusion
- Adult patients, aged between 18 and 75 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- 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;
- Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
- 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);
- Expected survival of ≥ 12 weeks.
Exclusion
- Subjects with poor-controlled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
- 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;
- Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
- With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- Associated with CNS (central nervous system) metastases;
- Active bacterial infections;
- Pregnant or breast-feeding women;
- Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03271073
Start Date
February 1 2016
End Date
January 31 2019
Last Update
September 1 2017
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050