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Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
paclitaxel-albumin and S-1
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. pathologically diagnosed gastric adenocarcinoma
  2. Type II and III esophageal-gastric-junction malignancy
  3. AJCC stage II-III
  4. No contraindications for surgery, radical resection can be expected
  5. KPS>60; ECOG score:0-2
  6. Expactant survival period>6 months
  7. Age 20~75
  8. No other major health issues

  9. Lab results within 7 days before inclusion must satisfy:

    1. neutrophil≥1.5×109/L
    2. PLT≥100×109/L
    3. hemogloblin≥90g/L
    4. ALT,AST<1.5 upper limit
    5. Tbil≤1.0×UNL
    6. serum creatinine<1.5×UNL
    7. PT-INR/PTT<1.7 upper limit
  10. with measurable lesion according to RECIST1.1 criteria
  11. with consent
  12. co-operative

Exclusion Criteria:

  1. with other major health issue
  2. allergic to relevant drugs
  3. experienced any other drug therapy with 4 weeks before inclusion
  4. experienced any drug therapy for gastric cancer at anytime
  5. diagnosed with any other malignancy within the past 5 years
  6. women at child-bearing age; pregnant or breast-feeding women
  7. with severe heart disease
  8. with upper GI digestion or disrupted absorption
  9. with peripheral neural disease
  10. with transplated organs or organs having been resected for transplantation
  11. known DPD deficiency
  12. with uncontrolled infection

Sites / Locations

  • Zhongtao Zhang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel-albumin and S-1

Arm Description

Outcomes

Primary Outcome Measures

DFS
disease free survival

Secondary Outcome Measures

ORR
objective response rate
OS
overall survival

Full Information

First Posted
February 5, 2020
Last Updated
February 5, 2020
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04258657
Brief Title
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
Official Title
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship 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
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.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel-albumin and S-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
paclitaxel-albumin and S-1
Intervention Description
neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer
Primary Outcome Measure Information:
Title
DFS
Description
disease free survival
Time Frame
3-year
Secondary Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
3-year
Title
OS
Description
overall survival
Time Frame
3-year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Lab results within 7 days before inclusion must satisfy: 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 with measurable lesion according to RECIST1.1 criteria with consent co-operative Exclusion Criteria: with other major health issue allergic to relevant drugs experienced any other drug therapy with 4 weeks before inclusion 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongtao Zhang
Phone
8618811792819
Ext
8618811792819
Email
zhongtao.z@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Deng
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongtao Zhang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongtao Zhang
Phone
8618811792819
Ext
8618811792819
Email
zhongtao.z@139.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

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