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 — DRUGSubject 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 SOXIn 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 ]