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

Advanced Esophageal Squamous Carcinoma Clinical Trial

Official title:

A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03193424
• Other study ID #: AHEAD-HNP001
• Status: Recruiting
• Phase: Phase 2
• First received: June 17, 2017
• Last updated: June 19, 2017
• Start date: October 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2017
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Qingxia Fan
• Phone: 13939039058
• Email: fqx2243[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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?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 ? myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms).According to NYHA standard, grade ? ~ ? 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.

Related Conditions & MeSH terms

• Advanced Esophageal Squamous Carcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms

Intervention

Drug:
• 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) .

Locations

Country	Name	City	State
China	FirstAHZhengzhouU	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	The first day of treatment to the date that disease progression is reported.	6 months
Secondary	Total Survival (OS)	the first day of treatment to death or last survival confirm date	up to 24 months