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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: paclitaxel-albumin and S-1

• Registration Number: NCT04258657
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06
• Study Start: 2020-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel-albumin and S-1	paclitaxel-albumin and S-1	-

Primary Outcome Measures

Name	Time	Method
DFS	3-year	disease free survival

Secondary Outcome Measures

Name	Time	Method
ORR	3-year	objective response rate
OS	3-year	overall survival

Trial Locations

Locations (1)

Zhongtao Zhang; 🇨🇳 Beijing, Beijing, China