Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

First Affiliated Hospital of Guangxi Medical University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: Docetaxel; Drug: Endostar; Drug: Nedaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03649945

HRGX06

Details and patient eligibility

About

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

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

Test Group 1

Active Comparator group

Description:

Docetaxel plus Nedaplatin combined with Endostar

Treatment:

Drug: Docetaxel

Drug: Endostar

Drug: Nedaplatin

Test Group 2

Active Comparator group

Description:

Docetaxel plus Nedaplatin

Treatment:

Drug: Docetaxel

Drug: Nedaplatin

Control Group

No Intervention group

Description:

No medicine intervention