Apatinib as First -Line Treatment for Advanced Esophagus Cancer

Phase 2

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

• Registration Number: NCT03542422
• Lead Sponsor: Affiliated Hospital of North Sichuan Medical College

Brief Summary

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Detailed Description

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:

Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14
• Study Start: 2018-06-30
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Age: 18 to 75 years old, men and women;
• 2. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
• 3. ECOG performance status: 0-2;
• 4. Life expectancy ≥ 12 weeks;
• 5. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;

• 6. Function of the major organs is normal, criteria referred are as follow:

  7. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;

  8. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;

  9. plasma examination Cr ≤ 1.5 ULN;

• 7. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
• 8. Patients that the investigator believes can benefit.

Exclusion Criteria

• 1. Those who have had other malignant tumors in the past or at the same time;
• 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, which significantly affects drug taking and absorption;
• 5. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
• 6.With coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg <2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
• 7. Have a mental illness, or history of abuse of psychotropic substances;
• 8. With anastomotic recurrence and tracheal fistula;
• 9. Patients who participated in other drug clinical trials within 4 weeks;
• 10. 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;
• 11. Researchers believe that it is not suitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib	Apatinib	Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

Primary Outcome Measures

Name	Time	Method
Progress free survival（PFS）	12months	Time subject into the group to tumor objective progression.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to12months	Time subject into the group to die

Trial Locations

Locations (1)

Affiliated Hospital of North Sichuan Medical College; 🇨🇳 Nanchong, Sichuan, China