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We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Combined With SOX | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApatinibMesylateTablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radical surgical resection rate | Radical surgical resection rate is defined as the rate of R0 resection | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response rate | 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. | 30 days |
| overall response rate |
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Inclusion Criteria:
Age from 18 to 75 years
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
Estimate life is equal or greater than 3 months
No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
The main organ function is normal,and meet the following criteria:
blood routine examination( No blood transfusion within 14 days)
blood biochemical examination
Written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34241629 | Derived | Lin JX, Xu YC, Lin W, Xue FQ, Ye JX, Zang WD, Cai LS, You J, Xu JH, Cai JC, Tang YH, Xie JW, Li P, Zheng CH, Huang CM. Effectiveness and Safety of Apatinib Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116240. doi: 10.1001/jamanetworkopen.2021.16240. |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D007267 | Injections |
| C104201 | gimeracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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|
|
according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 |
| 30 days |
| 5-year overall survival rate | 60 months |
| 5-year disease free survival rate | 60months |
| overall postoperative morbidity rates | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days |
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| 30 days mortality rates | Defined as the event observed within 30 days after surgery. | 30 days |
| adverse event | 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. | 60 months |
| D013812 |
| Therapeutics |