Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2021-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Group 1

Docetaxel plus Nedaplatin combined with Endostar

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Nedaplatin

Intervention Type DRUG

80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Endostar

Intervention Type DRUG

7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles

Test Group 2

Docetaxel plus Nedaplatin

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Nedaplatin

Intervention Type DRUG

80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Control Group

No medicine intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Docetaxel

75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Intervention Type DRUG

Nedaplatin

80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No