Clinical trial NCT02510469: Apatinib as Maintenance Therapy After Adjuvant Chemotherapy in Progressive Gastric Cancer With Positive Exfoliative Cancer Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2015-07-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive exfoliative cancer cells.

Detailed description: Eligible patients will recieve apatinib treatment(500mg qd p.o. q28d) for 6 cycles after 8 cycles of XELOX adjuvant chemotherapy or only XELOX adjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to75 years old;
2. ECOG PS of 0-1;
3. Histologically proven gastric cancer of stageⅡA, ⅡB, ⅢA, ⅢB and ⅢC (except level 3 or 4 lymph node high suspicious on imaging or confirm by biopsy. A minimun of 15 examined lymph nodes is recommended). All pts were received D2 gastrectomy;
4. The exfoliative cancer cells detection in peritoneal washes was positive;
5. Complete 8 cycles XELOX adjuvant chemotherapy and no recurrence / metastasis occurred. No more than 28 days from screening time to the end of chemotherapy; XELOX: Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d;
6. Pts never received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
7. 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
8. An expected survival of ≥ 3 months;
9. 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.
10. 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 ClassII; II-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac dysfunction;
3. 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;
4. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
5. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
6. Associated with Peritoneal, liver, CNS (central nervous system) or distant 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.

Primary outcomes:
measure: Disease free survival
timeFrame: An expected average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Affiliated Hospital of Hebei Medical University
state: Hebei
Study officials:
References: