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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04258657
• Other study ID #: BFH-GCCT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: Beijing Friendship Hospital
• Contact: Zhongtao Zhang
• Phone: 8618811792819
• Email: zhongtao.z[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• paclitaxel-albumin and S-1
neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer

Locations

Country	Name	City	State
China	Zhongtao Zhang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	disease free survival	3-year
Secondary	ORR	objective response rate	3-year
Secondary	OS	overall survival	3-year