Apatinib Treatment for Advanced Esophagus Cancer

NCT03170310 | Unknown Phase 2

• 1 other identifier: AHEAD-HNP006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progress free survival

  Time subject into the group to tumor objective progression.

  24 months

Secondary Outcomes (1)

• Overall survival

  up to 24 months

Study Arms (1)

Apatinib

EXPERIMENTAL

Drug: Apatinib

Interventions

Apatinib DRUG

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

Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 to 75 years old, men and women;
• \. 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.
• \. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
• \. ECOG PS:0-1;
• \. Life expectancy≥12 weeks;
• \. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
• \. The main organs function properly, that is, meet the following criteria:
• blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
• biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST\<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
• \. 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.
• \. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
• \. Investigator believe that subject who can benefit.

You may not qualify if:

• \. In the past or at the same time with suffered from other malignancies;
• \. Pregnant or lactating women;
• \. 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%;
• \. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorption;
• \. 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;
• \. Central nervous system metastasis has occurred;
• \. With abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• \. With mental illness, or mental history of drug abuse;
• \. With anastomotic recurrence;
• \. Patients who have participated in other drug clinical trials in 4 weeks;
• \. 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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

apatinib

Central Study Contacts

Ying Liu

CONTACT

13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: February 21, 2017
• Primary Completion: February 21, 2019
• Study Completion: September 21, 2019
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

CN (1)