Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Sponsor
Chang-Ming Huang, Prof.
Study ID
NCT03192735
Phase
PHASE2
Status
Unknown

Conditions

  • Apatinib Combined
  • Locally Advanced Gastric Cancer
  • Neoadjuvant Therapy
  • SOX

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ApatinibMesylateTablets — DRUG
    Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day,ivgtt,in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.

Study Details

We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)

Key Dates

Start date
Sep 1, 2017
Status verified
Feb 2020
Primary completion
Nov 11, 2019
Completion
Dec 11, 2024

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib Combined With SOX
    In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day,ivgtt,in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.

Primary Outcome Measure

Radical surgical resection rate [ Time Frame: 30 days ]