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Clinical Trials/NCT04258657
NCT04258657
Unknown
Phase 2

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

Beijing Friendship Hospital1 site in 1 country20 target enrollmentMarch 1, 2020

Overview

Phase
Phase 2
Intervention
paclitaxel-albumin and S-1
Conditions
Gastric Cancer
Sponsor
Beijing Friendship Hospital
Enrollment
20
Locations
1
Primary Endpoint
DFS
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 31, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhongtao Zhang

Professor

Beijing Friendship Hospital

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
  • No other major health issues
  • Lab results within 7 days before inclusion must satisfy:
  • neutrophil≥1.5×109/L
  • PLT≥100×109/L

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

Arms & Interventions

Paclitaxel-albumin and S-1

Intervention: paclitaxel-albumin and S-1

Outcomes

Primary Outcomes

DFS

Time Frame: 3-year

disease free survival

Secondary Outcomes

  • ORR(3-year)
  • OS(3-year)

Study Sites (1)

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