NCT03649945

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 26, 2018

Last Update Submit

August 26, 2018

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • overall survival

    3 years

Study Arms (3)

Test Group 1

ACTIVE COMPARATOR

Docetaxel plus Nedaplatin combined with Endostar

Drug: DocetaxelDrug: NedaplatinDrug: Endostar

Test Group 2

ACTIVE COMPARATOR

Docetaxel plus Nedaplatin

Drug: DocetaxelDrug: Nedaplatin

Control Group

NO INTERVENTION

No medicine intervention

Interventions

DocetaxelDRUG

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

Test Group 1Test Group 2
NedaplatinDRUG

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

Test Group 1Test Group 2
EndostarDRUG

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 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Docetaxelnedaplatinendostar protein

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 26, 2018

First Posted

August 28, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2020

Study Completion

May 1, 2021

Last Updated

August 28, 2018

Record last verified: 2018-08