Apatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer
Apatinib
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: July 1, 2015
Actual date on which the first participant was enrolled.Eligible patients will receive apatinib treatment(500mg qd p.o. q28d) until until disease progression or intolerable toxicity or patients withdrawal of consent after 4 cycles of DC first-line chemotherapy or only DC first-line chemotherapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Age: 18 to75 years old; 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: 1. Confirmed that apatinib and/or its accessories allergy; 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, ChinaOpen Fourth Affiliated Hospital of Hebei Medical University in Google Maps