Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03801668|
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Albumin-bound Paclitaxel plus S-1 Drug: Oxaliplatin plus S-1||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
Drug: Albumin-bound Paclitaxel plus S-1
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
Active Comparator: SOX
Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
Drug: Oxaliplatin plus S-1
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
- Progression-free Survival (PFS) [ Time Frame: up to 3 years ]PFS is defined as time from the start of treatment to progression of disease or death.
- Overall Response Rate (ORR) [ Time Frame: up to 3 years ]The rate of participants that achieve either a complete response (CR) or a partial response (PR).
- Overall survival (OS) [ Time Frame: up to 3 years ]Overall survival is defined as time from the start of treatment until death due to any reason.
- Safety as measured by number and grade of adverse events [ Time Frame: up to 3 years ]Summary adverse events according to NCI-CTCAE 4.03
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): NCT03801668
|Contact: Xianglin Yuan, MD,PhDemail@example.com|
|Contact: Hong Qiu, MD,PhDfirstname.lastname@example.org|
|Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Xianglin Yuan, MD,PHD 8627-83663406 email@example.com|
|Contact: Hong Qiu, MD,PHD 8627-83663406 firstname.lastname@example.org|
|Principal Investigator: Xianglin Yuan, MD,PHD|
|Sub-Investigator: Hong Qiu, MD,PHD|
|Study Chair:||Xianglin Yuan, MD,PhD||Tongji Hospital|