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

February 5, 2020 updated by: Zhongtao Zhang, Beijing Friendship Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Zhongtao Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel-albumin and S-1
Drug: paclitaxel-albumin and S-1
neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 3-year
disease free survival
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3-year
overall survival
3-year
ORR
Time Frame: 3-year
objective response rate
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: Wei Deng, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH-GCCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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