Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03192735|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Apatinib Combined SOX Neoadjuvant Therapy Locally Advanced Gastric Cancer||Drug: ApatinibMesylateTablets||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||November 11, 2019|
|Estimated Study Completion Date :||December 11, 2024|
Experimental: Apatinib Combined With SOX
In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
- Radical surgical resection rate [ Time Frame: 30 days ]Radical surgical resection rate is defined as the rate of R0 resection
- Pathological response rate [ Time Frame: 30 days ]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.
- overall response rate [ Time Frame: 30 days ]according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
- 5-year overall survival rate [ Time Frame: 60 months ]
- 5-year disease free survival rate [ Time Frame: 60months ]
- overall postoperative morbidity rates [ Time Frame: 30 days ]Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
- Duration of postoperative hospital stay [ Time Frame: 30 days ]Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
- 30 days mortality rates [ Time Frame: 30 days ]Defined as the event observed within 30 days after surgery.
- adverse event [ Time Frame: 60 months ]An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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): NCT03192735
|Fujian Medical University Union Hospital|
|Fuzhou, Fujian, China, 350000|