Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

NCT ID: NCT03193424

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-12-30

Brief Summary

Esophageal cancer is a common malignant tumor in china, occupies the second place of malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.

Conditions

Advanced Esophageal Squamous Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Apatinib

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .

docetaxel

Group Type: ACTIVE_COMPARATOR

Apatinib

Intervention Type: DRUG

Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .

Interventions

Apatinib

Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .

Intervention Type: DRUG

Other Intervention Names

Docetaxel

Eligibility Criteria

Inclusion Criteria

• Age: 18 years old to 75 years old, male and female is ok.
• Esophageal squamous cell carcinoma diagnosed by histopathology and immunohistochemistry. At least one treated measurable lesion (spiral CT scan length ≥10mm, in line with RESCIST version 1.1 standard requirements);
• Patients with advanced esophageal cancer treated by radiotherapy and treatment;
• ECOG PS Rating: 0-1 points;
• Expected survival ≥12 weeks;
• Without molecular targeted drug therapy.
• The main organ function is normal, that is to meet the following criteria:

Blood test:a.HB≥90 g/L；b.ANC≥1.5×109/L；c.PLT ≥80×109/L； Biochemical tests:a.ALB≥30g / L；b. ALT和AST<2ULN；ALT and AST <2ULN;c.TBIL≤1.5ULN；Plasma Cr ≤ 1.5ULN;

• Subjects volunteered to join the study, signed informed consent, compliance, with follow-up.
• Researchers believe that patients can benefit.

Exclusion Criteria

• Patients who have been confirmed to be allergic to apatinib and / or its excipients;
• Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy), with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
• Patients with a clear tendency to gastrointestinal bleeding, including the following: localized ulcer lesions, and fecal occult blood (++) can not be grouped; 2 months with black, hematemesis history;
• Coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), with bleeding tendency;
• (Eg, no swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) that affect the absorption of oral medications;
• The patients with active brain metastases(without medical control) , cancer meningitis, spinal cord compression, or screening of imaging CT or MRI examination found that the brain or pia mater disease (21 days before the completion of treatment and symptoms of stable brain Metastasis patients can be grouped, but the need for transcranial MRI, CT or intravenous angiography, confirmed as no cerebral hemorrhage symptoms)
• Pregnant or lactating women
• Subject with other malignancies within 5 years(except the skin basal cell carcinoma and cervical in situ cancer that have already cured )
• Subject with a history of psychiatric abuse and who can not be abused or have mental disorders;
• Subject who participated in other drug clinical trials within 4 weeks.
• Subject who have received VEGFR inhibitors such as sorafenib, sunitinib;
• According to the investigator's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study;
• Researchers think it is not suitable for inclusion.

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

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

FanQingxia

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FirstAHZhengzhouU

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingxia Fan

Role: CONTACT

fqx2243@126.com

13939039058

Lijie Song

Role: CONTACT

lijiesongcn@hotmail.com

13939020459

Facility Contacts

Qingxia Fan

Role: primary

fqx2243@126.com

139-3903-9058

Lijie Song

Role: backup

lijiesongcn@hotmail.com

139-3902-0459

Other Identifiers

AHEAD-HNP001

Identifier Type: -

Identifier Source: org_study_id