Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 6, 2020
February 1, 2020
2.8 years
February 5, 2020
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
DFS
disease free survival
3-year
Secondary Outcomes (2)
ORR
3-year
OS
3-year
Study Arms (1)
Paclitaxel-albumin and S-1
EXPERIMENTALInterventions
neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer
Eligibility Criteria
You may qualify if:
- pathologically diagnosed gastric adenocarcinoma
- Type II and III esophageal-gastric-junction malignancy
- AJCC stage II-III
- No contraindications for surgery, radical resection can be expected
- KPS\>60; ECOG score:0-2
- Expactant survival period\>6 months
- Age 20\~75
- No other major health issues
- neutrophil≥1.5×109/L
- PLT≥100×109/L
- hemogloblin≥90g/L
- ALT,AST\<1.5 upper limit
- Tbil≤1.0×UNL
- serum creatinine\<1.5×UNL
- PT-INR/PTT\<1.7 upper limit
- +3 more criteria
You may not qualify if:
- with other major health issue
- allergic to relevant drugs
- experienced any drug therapy for gastric cancer at anytime
- diagnosed with any other malignancy within the past 5 years
- women at child-bearing age; pregnant or breast-feeding women
- with severe heart disease
- with upper GI digestion or disrupted absorption
- with peripheral neural disease
- with transplated organs or organs having been resected for transplantation
- known DPD deficiency
- with uncontrolled infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongtao Zhang
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei Deng
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 6, 2020
Study Start
March 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 6, 2020
Record last verified: 2020-02