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

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: paclitaxel-albumin and S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT04258657

BFH-GCCT

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Paclitaxel-albumin and S-1

Experimental group

Treatment:

Drug: paclitaxel-albumin and S-1