Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

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

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Nedaplatin; Drug: Endostar

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test Group 1; Docetaxel plus Nedaplatin combined with Endostar	Drug: Docetaxel; 75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles; Drug: Nedaplatin; 80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles; Drug: 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
Active Comparator: Test Group 2; Docetaxel plus Nedaplatin	Drug: Docetaxel; 75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles; Drug: Nedaplatin; 80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
No Intervention: Control Group; No medicine intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	From the time of randomization to the time of death for any reason.	3 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: August 26, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Docetaxel; Endostar protein; Nedaplatin
• Other Study ID Numbers: HRGX06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No