Phase
Condition
Stomach Cancer
Gastric Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 18 to75 years old;
Histologically proven progressive gastric cancer. All pts were received D2 gastrectomyand recurrence / metastasis occured;
Complete 4 cycles DC first-line chemotherapy and no and no disease progressionoccurred. DC: Docetaxel 60-85mg/m2 iv d1, Cisplatin 60-75mg/m2 iv d1, q21d;
ECOG PS of 0-1;
Major organ function has to meet the following criteria: ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; Bilirubin <1.5 times the upperlimit of normal (ULN); ALT and AST <2.5 × ULN; liver metastases, if any, the ALT andAST<5 × ULN;
An expected survival of ≥ 3 months;
Pregnancy test (serum or urine) has to be performed for woman of childbearing agewithin 7 days before enrolment and the test result must be negative. They shall takeappropriate methods for contraception during the study until the 8th week post thelast administration of study drug. For men, (previous surgical sterilizationaccepted), shall agree to take appropriate methods of contraception during the studyuntil the 8th week post the last administration of study drug.
Patient has to voluntarily join the study and sign the Informed Consent Form for thestudy;
Exclusion
Exclusion Criteria:
Confirmed that apatinib and/or its accessories allergy;
Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHgand diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronaryheart disease greater than ClassI; I-level arrhythmia (including QT intervalprolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiacdysfunction;
Factors that could have an effect on oral medication (such as inability to swallow,chronic diarrhea and intestinal obstruction);
Subjects with high gastrointestinal bleeding risk, including the following conditions:local active ulcer lesions with positive fecal occult blood test (++); history ofblack stool, or vomiting blood in the past 2 months;
Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
Associated with CNS (central nervous system) metastases;
Pregnant or lactating women;
Pts with other malignant tumor within 5 years(except cured skin basal cell carcinomaand cervical carcinoma);
With psychotropic drug abuse history and can't get rid of or mental disorder patients;
Participated in other clinical trials within 4 weeks.
Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
Any other condition that might place the patient at undue risk or preclude a patientfrom completing the study;
Other conditions regimented at investigators' discretion.
Study Design
Study Description
Connect with a study center
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei 050011
ChinaActive - Recruiting

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