Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03649945
• Other study ID #: HRGX06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: May 2021

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 186
• Est. completion date: May 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.

• R0 resection has been performed at least before 4 weeks.

• ECOG PS score: 0-1 points.

• Estimated survival time: at least 12 weeks.

• No radiotherapy, chemotherapy or molecular targeted therapy before.

• Main organs are functional, which meet the following criteria:

Blood Routine:

HB=90 g/L(No blood transfusion within 14 days), ANC=1.5×109/L, PLT =80×109/L. Biochemical examination: ALB=30g / L(No blood transfusion within 14 days), ALT<2ULN; AST<2ULN TBIL=1.5ULN; Plasma Cr=1.5ULN;

• Volunteer with signed informed consent form, good compliance and good follow-up cooperation.

• Patients who the investigator believws they can benefit.

Exclusion Criteria:

• Those who have had other malignant tumors in the past or at the same time.

• Pregnant or lactating women.

• Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval = 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%.

• Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.

• Have a history of mental illness or psychotropic substance abuse.

• Patients who have participated in other drug clinical trials within 4 weeks.

• According to the investigator's judgment, patients who are at a risk or have accompanying disease.

• Patients who believe that they are unsuitable for inclusion.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Docetaxel
75mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles
• Nedaplatin
80 mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles
• Endostar
7.5mg/m2,once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year disease-free survival rate	the percentage of the patients whose disease cannot be detected after curative therapy in three years	3 years
Secondary	overall survival	From the time of randomization to the time of death for any reason.	3 years