Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA

Sponsor
Fujian Cancer Hospital
Study ID
NCT03030937
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).
  • Irinotecan — DRUG
    Irinotecan was used as second line treatment with AGC.

Study Details

The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.

Key Dates

Start date
Feb 1, 2017
Status verified
Jan 2017
Primary completion
Jul 31, 2018
Completion
Dec 30, 2018

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan plus apatinib
    Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ). Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
  • Active Comparator: Irinotecan
    Irinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 18 months ]

Central Contacts