Clinical trial · Interventional
Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer
NCT03263741CI-TRIAL-00039386unknownPhase 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)
Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or 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 + S-1 + Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel + S-1 + Oxaliplatin group
- description
- Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
- interventionNames
- Drug: Paclitaxel + S-1 + Oxaliplatin
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- 2 years
- description
- The sum of complete remission (CR) rate and partial remission (PR) rate.
Secondary outcomes (3)
- measure
- Progression-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma; 2. Locally advanced, or recurrent, or metastasis disease; 3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed; 4. Life expectancy of at least 3 months; 5. ECOG score 0-1; 6. Age: 18\~70 years old; 7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl; 8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases; 9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver); 10. Not participating in other study projects before and during the treatment; 11. Voluntarily signed the informed consent. Exclusion Criteria: 1. Previously treated with first-line chemotherapy; 2. Allergy to the drugs in this protocol; 3. Pregnant or lactating women; 4. Women at childbearing age and of pregnancy desire during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.