Clinical trial · Interventional
Apatinib Treatment for Advanced Esophagus Cancer
Apatinib Treatment for Advanced Esophagus Cancer ,One-armed,Exploratory,Openting , Clinical Trail.
NCT03170310CI-TRIAL-00027925unknownPhase 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)
Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.
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
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progress free survival
- timeFrame
- 24 months
- description
- Time subject into the group to tumor objective progression.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- up to 24 months
- 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\. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy. * 3\. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy; * 4\. ECOG PS:0-1; * 5\. Life expectancy≥12 weeks; * 6\. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy; * 7\. The main organs function properly, that is, meet the following criteria: 1. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L; 2. biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST\<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN; * 8\. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment. * 9\. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up; * 10\. Investigator believe that subject who can benefit. Exclusion Criteria: * 1\. In the past or at the same time with suffered from other malignancies; * 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, significantly affect the drug taking and absorption; * 5\. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds; * 6\. Central nervous system metastasis has occurred; * 7\. With abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; * 8\. With mental illness, or mental history of drug abuse; * 9\. With anastomotic recurrence; * 10\. Patients who have participated in other drug clinical trials in 4 weeks; * 11\. 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; * 12\. Patients those researchers believe not suitable for the inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.