Clinical trial · Interventional
Apatinib as First -Line Treatment for Advanced Esophagus Cancer
An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.
NCT03542422CI-TRIAL-00033305unknownPhase 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)
An Exploratory study of Amapinib for patients with advanced esophagus 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 |
|---|---|---|---|
| Advanced Esophagus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progress free survival(PFS)
- timeFrame
- 12months
- description
- Time subject into the group to tumor objective progression.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- up to12months
- description
- Time subject into the group to die
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age: 18 to 75 years old, men and women; * 2\. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry; * 3\. ECOG performance status: 0-2; * 4\. Life expectancy ≥ 12 weeks; * 5\. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ; * 6\. Function of the major organs is normal, criteria referred are as follow: 1. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L; 2. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST \<5 ULN; TBIL ≤ 1.5 ULN; 3. plasma examination Cr ≤ 1.5 ULN; * 7\. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up; * 8\. Patients that the investigator believes can benefit. Exclusion Criteria: * 1\. Those who have had other malignant tumors in the past or at the same time; * 2\. Pregnant or lactating women; * 3\. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure\>150mmHg, diastolic blood pressure\>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ\~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF \<50%; * 4\. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption; * 5\. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months; * 6.With coagulation abnormalities (PT\>16 s, APTT\>43 s, TT\>21 s, Fbg \<2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy; * 7\. Have a mental illness, or history of abuse of psychotropic substances; * 8\. With anastomotic recurrence and tracheal fistula; * 9\. Patients who participated in other drug clinical trials within 4 weeks; * 10\. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment; * 11\. Researchers believe that it is not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.