Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Condition: Advanced or Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: apatinib; placebo
Intervention description: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent; placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention MeSH terms: Apatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor
      receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable and the maximum
      tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib
      can improve progression free survival or overall survival compared with placebo in patients
      with metastatic gastric carcinoma who failed two lines of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 and ≤ 70 years of age

          -  Histological confirmed advanced or metastatic adenocarcinoma of the stomach

          -  Have failed for at least 2 lines of chemotherapy

          -  Life expectancy of at least 12 weeks.

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before
             randomization.

          -  At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral
             CT scan)

          -  Duration from the last therapy is more than 6 weeks for nitroso or mitomycin

          -  More than 4 weeks for operation or radiotherapy

          -  More than 4 weeks for cytotoxic agents or growth inhibitors

          -  Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80
             ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of
             normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma
             in-situ of uterine cervix Hypertension and unable to be controlled within normal level
             following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg,
             diastolic blood pressure > 90 mmHg).

          -  Any factors that influence the usage of oral administration; Evidence of Central
             Nerves System(CNS) metastasis

          -  Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart
             failure and proteinuria ≥ (+)

          -  International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin
             time（APPT） > 1.5 × ULN

          -  Abuse of alcohol or drugs

          -  Certain possibility of gastric or intestine hemorrhage

          -  Less than 4 weeks from the last clinical trial

          -  Prior VEGFR inhibitor treatment

          -  Disability of serious uncontrolled intercurrence infection Objective evidence of
             previous or current pulmonary fibrosis history, interstitial pneumonia,
             Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function
             damaged seriously etc.