Apatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer

Last updated: October 5, 2017
Sponsor: Hebei Medical University
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02509806
Ahead-G309
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive Gastric Cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 18 to75 years old;

  2. Histologically proven progressive gastric cancer. All pts were received D2 gastrectomyand recurrence / metastasis occured;

  3. 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;

  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 upperlimit of normal (ULN); ALT and AST <2.5 × ULN; liver metastases, if any, the ALT andAST<5 × ULN;

  6. An expected survival of ≥ 3 months;

  7. 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.

  8. Patient has to voluntarily join the study and sign the Informed Consent Form for thestudy;

Exclusion

Exclusion Criteria:

  1. Confirmed that apatinib and/or its accessories allergy;

  2. 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;

  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 ofblack 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 carcinomaand 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 patientfrom completing the study;

  13. Other conditions regimented at investigators' discretion.

Study Design

Total Participants: 48
Study Start date:
July 01, 2015
Estimated Completion Date:
December 31, 2017

Study Description

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.

Connect with a study center

  • Fourth Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

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