Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer PatientsWith lymph node metastasis
This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With lymph node metastasis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
three weeks is one cycle, 4 cycles followed by radical gastrectomy. Apatinib: 250 mg, p.o., qd, every 3 weeks for the first two cycles. if no level 3 or severer AEs happened, change apatinib to 500mg, p.o.,qd, otherwise keep 250mg in the third cycle. no apatinib in the fourth cycle. Capecitabine: 1000mg/m2, p.o., bid, D1-14, every 3 weeks (treatment for 2 weeks and rest 1 week). Oxaliplatin: 130mg/m2, i.v. over 2h, D1, every 3 weeks.
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR)
Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Time frame: 3 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety of the the perioperative treatment, percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments
Time frame: 30 days
Pathological response rate (pRR)
Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.
Time frame: 30 days
3-year disease free survival rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
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