Apatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer
NCT ID: NCT02509806
Last Updated: 2017-10-09
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/PHASE3
48 participants
INTERVENTIONAL
2015-07-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apatinib Maintenance Therapy After First-line Chemotherapy
Apatinib Mesylate Tablets 500 mg qd p.o. after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d）
Apatinib
Apatinib Mesylate Tablets 500 mg qd p.o.
No Intervention After First-line Chemotherapy
No Intervention after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d）
No interventions assigned to this group
Interventions
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Apatinib
Apatinib Mesylate Tablets 500 mg qd p.o.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically proven progressive gastric cancer. All pts were received D2 gastrectomy and recurrence / metastasis occured;
3. Complete 4 cycles DC first-line chemotherapy and no and no disease progression occurred. DC: Docetaxel 60-85mg/m2 iv d1, Cisplatin 60-75mg/m2 iv d1, q21d;
4. ECOG PS of 0-1;
5. 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 upper limit of normal (ULN); ALT and AST \<2.5 × ULN; liver metastases, if any, the ALT and AST\<5 × ULN;
6. An expected survival of ≥ 3 months;
7. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Exclusion Criteria
2. 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 II cardiac dysfunction;
3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
4. 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;
5. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
6. Associated with CNS (central nervous system) metastases;
7. Pregnant or lactating women;
8. Pts with other malignant tumor within 5 years(except cured skin basal cell carcinoma and cervical carcinoma);
9. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
10. Participated in other clinical trials within 4 weeks.
11. Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
12. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
13. Other conditions regimented at investigators' discretion.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Hebei Medical University
OTHER
Responsible Party
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Qun Zhao
Principal Investgator
Locations
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Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Other Identifiers
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Ahead-G309
Identifier Type: -
Identifier Source: org_study_id