Clinical trial · Interventional
The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
NCT02038621CI-TRIAL-00013479GZH-001unknownPhase 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)
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
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 |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin and Capecitabine | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.
- interventionNames
- Drug: Paclitaxel
- Drug: Oxaliplatin and Capecitabine
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Observation until progression
- interventionNames
- Drug: Paclitaxel
- Drug: Oxaliplatin and Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * male or female * Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ; * ECOG performance status score 0-2 ; * Expected survival time more than three months ; * Adequate hematologic parameters and liver and kidney function ; * Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L; * Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ; * Renal : serum creatinine ≤ ULN ; * Informed consent of patients or their agents , and signed informed consent. Exclusion Criteria: * For patients allergic to capecitabine ; * Patients with CNS metastases * Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ; * Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ; * Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ; * Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ; * The researchers believe that this test is not suitable for those who participate .
References
Publications (0)
Data not yet available
No reference posted for this study.