Clinical trial · Interventional
Study of Apatinib in Metastatic Esophageal Cancer
Study of Apatinib in Metastatic Esophageal Cancer:A Open Label, Randomized Clinical Trial
NCT02683655CI-TRIAL-00020932unknownPhase 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)
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal 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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib 500mg qd p.o.
- description
- Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy
- interventionNames
- Drug: Apatinib
- type
- EXPERIMENTAL
- label
- Apatinib 750mg qd p.o.
- description
- Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- An expected average of 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 to75 years old; 2. Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1); 3. Failed in first-line chemotherapy or radiotherapy treatment; 4. ECOG PS of 0-1; 5. An expected survival of ≥ 3 months; 6. No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored; 7. Major organ function has to meet the following criteria: ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST\<2 × ULN; Plasma Cr\<1.5 × ULN 8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study; 9. Researchers believe that patients can benefit; Exclusion Criteria: 1. Pts with other malignant tumor at the same time or in the past. 2. Pregnant or lactating women; 3. Subjects with poor-controlled arterial hypertension (systolic blood pressure\>150 mmHg and diastolic blood pressure\>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)\<50%; 4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months; 6. Associated with CNS (central nervous system) metastases; 7. Abnormal Coagulation, with tendency of bleed; 8. With psychotropic drug abuse history and can't get rid of or mental disorder patients; 9. Anastomotic recurrence; 10. Participated in other clinical trials within 4 weeks; 11. Any other condition that might place the patient at undue risk or preclude a patient from completing the study; 12. Other conditions regimented at investigators' discretion.
References
Publications (0)
Data not yet available
No reference posted for this study.