Gastric Cancer Clinical Trial
Official title:
Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy occasionally converts it to a resectable cancer. Previous studies showed patients with ELM gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of ELM 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
:425mg, 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 downregulation 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. 3-4 cycles of neoadjuvant
chemotherapy before surgery, stop Apatinib in the last cycle.4 cycles of adjuvant
chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
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