A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03258034|
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: SPA||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer|
|Estimated Study Start Date :||August 24, 2017|
|Estimated Primary Completion Date :||August 22, 2020|
|Estimated Study Completion Date :||October 22, 2021|
Experimental: Conversion treatment
after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.
S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily
- 3 year OS [ Time Frame: 3 years ]The overall survival time
- radical resection rate [ Time Frame: 4 months ]the radical resection rates
- 3 year DFS [ Time Frame: 3 years ]the diesease free survival time
- 5 year OS [ Time Frame: 5 years ]The overall survival time
- adverse events [ Time Frame: 7months ]number and degree of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258034
|The first affiliated hospital of zhejiang chinese medical university|
|Hanzhou, Zhejiang, China, 310006|
|Study Director:||Xiangdong Cheng, MD||The First Affiliated Hospital of Zhejiang Chinese Medical University|