Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02163291|
Recruitment Status : Unknown
Verified June 2014 by Jiafu Ji, Peking University.
Recruitment status was: Not yet recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Carcinoma||Drug: paclitaxel liposome||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: paclitaxel liposome
S-1 plus paclitaxel liposome
Drug: paclitaxel liposome
S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response（CR）,partial regression（PR） or stable disease（SD）, another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease（PD）, chemotherapy is stopped and operation is performed.
- Pathological complete response rate [ Time Frame: up to 24 weeks ]Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated.
- Object Response Rate [ Time Frame: up to 24 weeks ]Object Response Rate(ORR) is defined as the percentage of CR and PR among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Object Response Rate will be accessed after all of the 30 participants operated.
- Disease Control Rate [ Time Frame: up to 24 weeks ]Disease Control Rate(DC R) is defined as the percentage of CR+PR+SD among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Disease Control Rate will be accessed after all of the 30 participants operated.
- Number of Participants with Adverse Eventss a Measure of Safety and Tolerability [ Time Frame: up to 12 weeks ]Participants will be followed during all the s a Measure of Safety and Tolerability4 circles of chemotherapy ,an expected average of 12 weeks.Number of participants with Adverse Events will calculated as a Measure of Safety and Tolerability.
- R0 rate, surgical morbidity and mortality [ Time Frame: 2 weeks ]The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks .
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): NCT02163291
|Contact: Jiafu Ji, M.D.||email@example.com|
|Peking University Cancer Hospital|
|Haidian District, Beijing, China, 100142|
|Contact: Ziyu Li, M.D. firstname.lastname@example.org|
|Contact: Zhaodong Xing, M.D. email@example.com|
|Principal Investigator: Jiafu Ji, M.D.|
|Sub-Investigator: Ziyu Li, M.D.|
|Sub-Investigator: Kan Xue, M.D.|
|Sub-Investigator: Zhaodong Xing, MD|
|Principal Investigator:||Jiafu Ji, M.D.||Beijing Cancer Hospital|