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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258657

Enrollment

Registered

2020-02-06

Start date

2020-03-01

Completion date

2022-12-31

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

DRUGpaclitaxel-albumin and S-1

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
DFS	3-year	disease free survival

Secondary

Measure	Time frame	Description
ORR	3-year	objective response rate
OS	3-year	overall survival

Countries

China

Contacts

Primary ContactZhongtao Zhang

zhongtao.z@139.com8618811792819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026