Apatinib Treatment for Advanced Esophagus Cancer

Phase 2

• Conditions: Advanced Esophagus Cancer
• Interventions: Drug: Apatinib

• Registration Number: NCT03170310
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-21
• Status Verified: 2017-05
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Study First Posted: 2017-05-31
• Last Update Posted: 2017-05-31
• Primary Completion: 2019-02-21
• Study Completion: 2019-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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:

  8. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;

  9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib	Apatinib	-

Primary Outcome Measures

Name	Time	Method
Progress free survival	24 months	Time subject into the group to tumor objective progression.

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 24 months	Time subject into the group to die.

Trial Locations

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university; 🇨🇳 ZhengZhou, Henan, China