Apatinib Treatment for Advanced Esophagus Cancer

Advanced Esophagus Cancer Clinical Trial

Official title:

Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170310
• Other study ID #: AHEAD-HNP006
• Status: Recruiting
• Phase: Phase 2
• First received: May 26, 2017
• Last updated: May 26, 2017
• Start date: February 21, 2017
• Est. completion date: September 21, 2019

Study information

• Verified date: May 2017
• Source: Henan Cancer Hospital
• Contact: Ying Liu
• Phone: 13783604602
• Email: yaya7207[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ? or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval=450ms) and ?~? 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.

Related Conditions & MeSH terms

• Advanced Esophagus Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Apatinib
Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	ZhengZhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival	Time subject into the group to tumor objective progression.	24 months
Secondary	Overall survival	Time subject into the group to die.	up to 24 months