Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03258034
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2017-08-20
Brief Title:
A Feasibility Study for Convernsion Therapy Using S1Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
Phase II Study of Convernsion Therapy Using S1Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prognosis of Extensive lymph nodes metastaticELM 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 S1Paclitaxel chemotherapy plus Apatinib in the conversion therapys of ELM gastric cancer
Detailed Description:
The investigators will apply SPA regimen for coversional therapy to abtain high response rate Paclitaxel150 mgm2 iv3h 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 IV 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 cycle4 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery
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 IV 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 cycle4 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None