Clinical trial · Interventional
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
NCT03889626CI-TRIAL-00037772unknownPhase 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 evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib | — | UNRESOLVED | — |
| Capecitabine | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Molecular Mechanisms of Pharmacological Action | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Stomach Diseases | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
- interventionNames
- Drug: Apatinib
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
- interventionNames
- Drug: Capecitabine
- type
- NO_INTERVENTION
- label
- Observation
- description
- In this arm, no additional treatment will be given, and patients will be followed up at regular time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma * ECOG PS 0-2 * At least one measurable or evaluable lesion in the first-line chemotherapy * The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD * The time from the last cycle treatment to the enrollment cannot exceed 6 weeks * Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN) Exclusion Criteria: * Received 2 or more regimens for palliative chemotherapy * Pregnant or lactating women * Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction * Clinically significant active bleeding, OB 2+ or higher * Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia * Uncontrolled significant comorbid conditions
References
Publications (0)
Data not yet available
No reference posted for this study.