Study of Apatinib in Metastatic Esophageal Cancer

NCT02683655 | Unknown Phase 2

• 1 other identifier: Ahead-E301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  An expected average of 12 weeks

Study Arms (2)

Apatinib 500mg qd p.o.

EXPERIMENTAL

Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy

Drug: Apatinib

Apatinib 750mg qd p.o.

EXPERIMENTAL

Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib 500mg qd p.o.

Apatinib 500mg qd p.o.

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 to75 years old;
• Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
• Failed in first-line chemotherapy or radiotherapy treatment;
• ECOG PS of 0-1;
• An expected survival of ≥ 3 months;
• No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored;
• Major organ function has to meet the following criteria:
• ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST\<2 × ULN; Plasma Cr\<1.5 × ULN
• Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
• Researchers believe that patients can benefit;

You may not qualify if:

• Pts with other malignant tumor at the same time or in the past.
• Pregnant or lactating women;
• Subjects with poor-controlled arterial hypertension (systolic blood pressure\>150 mmHg and diastolic blood pressure\>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)\<50%;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;
• Associated with CNS (central nervous system) metastases;
• Abnormal Coagulation, with tendency of bleed;
• With psychotropic drug abuse history and can't get rid of or mental disorder patients;
• Anastomotic recurrence;
• Participated in other clinical trials within 4 weeks;
• Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Huai'an First People's Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Huaian First People's Hospital

Huaian, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Chen xiaofei, MD

CONTACT

+86-13915107001

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (1)