Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Drug: Docetaxel; Drug: Nedaplatin; Drug: Endostar

• Registration Number: NCT03649945
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-26
• Study First Submitted QC: 2018-08-26
• Last Update Submitted: 2018-08-26
• Study First Posted: 2018-08-28
• Last Update Posted: 2018-08-28
• Study Start: 2018-11
• Primary Completion: 2020-11
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group 1	Docetaxel	Docetaxel plus Nedaplatin combined with Endostar
Test Group 1	Nedaplatin	Docetaxel plus Nedaplatin combined with Endostar
Test Group 2	Docetaxel	Docetaxel plus Nedaplatin
Test Group 2	Nedaplatin	Docetaxel plus Nedaplatin
Test Group 1	Endostar	Docetaxel plus Nedaplatin combined with Endostar

Primary Outcome Measures

Name	Time	Method
3 year disease-free survival rate	3 years	the percentage of the patients whose disease cannot be detected after curative therapy in three years

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	From the time of randomization to the time of death for any reason.