Apatinib Treatment for Advanced Esophagus Cancer

NCT ID: NCT03170310

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2019-09-21

Brief Summary

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

Conditions

Advanced Esophagus Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

Interventions

Apatinib

Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Liu

Role: CONTACT

Phone: 13783604602

Email: yaya7207@126.com

Facility Contacts

Ying Liu, MD

Role: primary

Other Identifiers

AHEAD-HNP006

Identifier Type: -

Identifier Source: org_study_id