Clinical trial · Interventional
Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
- 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 randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status. The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Her2 Positive with SOX
- description
- Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
- interventionNames
- Drug: S-1
- Drug: Oxaliplatin
- type
- EXPERIMENTAL
- label
- Her2 Positive with SOXT
- description
- Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
- interventionNames
- Drug: S-1
- Drug: Trastuzumab
- Drug: Oxaliplatin
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma; 2. The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); * HER2 positive: IHC 3+ or IHC 2+/ FISH amplification. * HER2 negative: IHC 0, 1+ or IHC 2+/ FISH without amplification. 3. T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma; 4. Chemotherapy and radiotherapy naïve. 5. Age ≥18 years; 6. ECOG(Eastern Cooperative Oncology Group ) 0-1; 7. Adequate hematological, hepatic and renal functions: absolute neutrophil count (ANC) ≥ 2.0 G/L, hemoglobin ≥ 90g/L, platelet ≥ 100 G/L; ALT and AST \<1.5 times x upper limit of normal (ULN)；serum total bilirubin \< 1.0 x ULN; serum creatinine \< 1.0 x ULN; 8. Left ventricular ejection fraction\>50% 9. Written informed consent. Exclusion criteria: 1. Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma 2. History of allergies to drugs in the study 3. Intraperitoneal dissemination or distant metastasis 4. Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites 5. Dysphagia 6. Any cause of cirrhosis 7. Cardiac function NYHA(New York Heart Association) \>I degrees 8. Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia 9. Any surgical contraindication 10. Any chemotherapy or radiotherapy history 11. Any surgical resection history of gastric cancer 12. History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix 13. Any contraindication for chemotherapy
References
Publications (0)
Data not yet available