Apatinib as Maintenance Therapy After Adjuvant Chemotherapy in Progressive Gastric Cancer With Positive Exfoliative Cancer Cells

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Apatinib

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • Fourth Affiliated Hospital of Hebei Medical University
      • Principal Investigator: Zhao Qun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib Maintenance Therapy After Adjuvant Chemotherapy; Apatinib Mesylate Tablets 500 mg qd p.o. after XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d)	Drug: Apatinib; Apatinib Mesylate Tablets 500 mg qd p.o.; Other Names: ATAN
No Intervention: Only Adjuvant Chemotherapy; No Intervention After XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	An expected average of 2 years

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 26, 2015
• First Submitted That Met QC Criteria: July 26, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Ahead-G315