Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT04047953|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2026|
Experimental: Conversion Therapy
Paclitaxel (albumin-bound) +S-1+Oxaliplatin
Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg，bid, d1-14( BSA<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.
- R0 resection rate [ Time Frame: within 4 weeks following the operation ]Proportion of patients who achieved R0 resection
- Progression free survival (PFS) [ Time Frame: 5 years ]the time from registration to the date of disease progression or death resulting from any cause.
- overall survival (OS) [ Time Frame: 5 years ]the time from registration to the date of death resulting from any cause or the last follow-up visit.
- Adverse Events(AEs) [ Time Frame: until 28 days after the last study drug administration ]AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
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): NCT04047953
|Contact: Jiafu ji, MDfirstname.lastname@example.org|
|Contact: Zhaode Bu, MDemail@example.com|
|Beijing Cancer Hospital||Not yet recruiting|
|Beijing, Beijing, China|
|Contact: Jiafu Ji, MD 86-010-88196048 firstname.lastname@example.org|
|Contact: Zhaode Bu, MD 86-010-88196945 email@example.com|
|Principal Investigator: Jiafu Ji, MD|
|Principal Investigator: Zhaode Bu, MD|
|Principal Investigator:||Jiafu ji, MD||Beijing Cancer Hospital|
|Principal Investigator:||Zhaode Bu, MD||Beijing Cancer Hospital|