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Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Docetaxel

Nedaplatin

Endostar

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Test Group 1

Test Group 2

Control Group

Arm Description

Docetaxel plus Nedaplatin combined with Endostar

Docetaxel plus Nedaplatin

No medicine intervention

Outcomes

Primary Outcome Measures

3 year disease-free survival rate

the percentage of the patients whose disease cannot be detected after curative therapy in three years

Secondary Outcome Measures

overall survival

From the time of randomization to the time of death for any reason.

Full Information

NCT ID

NCT03649945

First Posted

August 26, 2018

Last Updated

August 26, 2018

Sponsor

First Affiliated Hospital of Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03649945

Brief Title

Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test Group 1

Arm Type

Active Comparator

Arm Description

Docetaxel plus Nedaplatin combined with Endostar

Arm Title

Test Group 2

Arm Type

Active Comparator

Arm Description

Docetaxel plus Nedaplatin

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

No medicine intervention

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nedaplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Endostar

Intervention Description

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

Primary Outcome Measure Information:

Title

3 year disease-free survival rate

Description

the percentage of the patients whose disease cannot be detected after curative therapy in three years

Time Frame

3 years

Secondary Outcome Measure Information:

Title

overall survival

Description

From the time of randomization to the time of death for any reason.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

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