Clinical trial · Interventional
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
NCT04258657CI-TRIAL-00043248unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel-albumin and S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel-albumin and S-1
- interventionNames
- Drug: paclitaxel-albumin and S-1
Primary outcomes (1)
- measure
- DFS
- timeFrame
- 3-year
- description
- disease free survival
Secondary outcomes (2)
- measure
- ORR
- timeFrame
- 3-year
- description
- objective response rate
- measure
- OS
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.