Back to resultsNab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nab-paclitaxel combined with S-1
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- gastric cancer patients after radical resection
- diffuse type gastric cancer stage III
Exclusion Criteria:
- Patients who have metastasis disease
- Patients who can not tolerate chemotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nab-paclitaxel combined with S-1
Arm Description
Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
Outcomes
Primary Outcome Measures
Recommended dose for Phase II study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977220
Brief Title
Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer
Official Title
Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
Detailed Description
Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nab-paclitaxel combined with S-1
Arm Type
Experimental
Arm Description
Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel combined with S-1
Intervention Description
Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
Primary Outcome Measure Information:
Title
Recommended dose for Phase II study
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gastric cancer patients after radical resection
diffuse type gastric cancer stage III
Exclusion Criteria:
Patients who have metastasis disease
Patients who can not tolerate chemotherapy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer
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