Gastric Cancer Clinical Trial
Official title:
A Prospective Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer
The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of initially unresectable metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of metastatic gastric cancer.
The investigators will apply SPA regimen for coversional therapy to abtain high response
rate.
Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose :500mg,
QD, after meal ( try to take the medicine at the same time of the day ).
Dose adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the
patient totally recovers from the toxic reaction after the regulation, we could up-regulate
the dosage back to the former level. If the down-regulation occurs again according to the
protocol , then the up-regulation will be forbidden.
S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the
following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks,
then suspend for 1 week.
Preventive medication: To prevent serious allergic reaction of Paclitaxel, preventive
medication should be given in advance. We usually give dexamethasone 20mg orally 12 and 6
hours before the Paclitaxel, and diphenhydramine (or something analogous) 50 mg, cimetidine
300mg (or ranitidine 50mg) I.V. 30-60 minutes before the Paclitaxel.
Repeat the therapeutic schedule every 3 weeks. 3 cycles of neoadjuvant chemotherapy before
surgery, stop Apatinib in the last cycle.
3 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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