Clinical trial · Interventional
An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric
NCT03285906CI-TRIAL-00029583unknownPhase 2 / Phase 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 Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Gastric Cardia Type Metaplasia | — | UNRESOLVED | — |
| Esophagus Cancer, Stage III | — | UNRESOLVED | — |
| Esophagus Cancer, Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Apatinib：500 mg，po，qd
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- Through study completion, an average of 1 year
- description
- No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.
Secondary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- Through study completion, an average of 0.5 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 and ≤ 75 years of age * Have failed for 1 lines of chemotherapy * ECOG performance scale 0 - 2. * Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min. * Life expectancy of more than 12 months Exclusion Criteria: * Existing therapy related toxicity of prior chemotherapy and/or radiation therapy * Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * Any factors that influence the usage of oral administration * The center of the tumor invaded local large blood vessels * Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3). * Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * Less than 4 weeks from the last clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.