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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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