Clinical trial · Interventional
Metronomic Capecitabine in Stage III Gastric Cancer
Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial
NCT06313567CI-TRIAL-00078605recruitingPhase 3ClinicalTrials.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)
The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metronomic capecitabine group | Drug | — | UNRESOLVED |
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metronomic capecitabine
- description
- Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
- interventionNames
- Drug: Metronomic capecitabine group
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy group
- description
- Observation after completion of standard adjuvant chemotherapy,
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old. 2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences 3. R0 gastrectomy with D2 lymphadenectomy 4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months 5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L). Exclusion Criteria: 1. History of chemotherapy, radiotherapy, immunotherapy or target therapy 2. Multiple primary tumors 3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases 4. Unavailable for R0 resection and D2 lymph node dissection. 5. Patients with stage IV gastric cancer
References
Publications (0)
Data not yet available
No reference posted for this study.