NCT03542422

Brief Summary

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

May 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

May 18, 2018

Last Update Submit

June 12, 2018

Conditions

Advanced Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

  • Progress free survival（PFS）

    Time subject into the group to tumor objective progression.

    12months

Secondary Outcomes (1)

  • Overall Survival

    up to12months

Study Arms (1)

Apatinib

EXPERIMENTAL

Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

Drug: Apatinib

Interventions

ApatinibDRUG

Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.

Also known as: yew, platinum
Apatinib

Eligibility Criteria

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

You may qualify if:

  • \. Age: 18 to 75 years old, men and women;
  • \. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
  • \. ECOG performance status: 0-2;
  • \. Life expectancy ≥ 12 weeks;
  • \. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;
  • \. Function of the major organs is normal, criteria referred are as follow:
  • blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
  • biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST \<5 ULN; TBIL ≤ 1.5 ULN;
  • plasma examination Cr ≤ 1.5 ULN;
  • \. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
  • \. Patients that the investigator believes 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 high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure\>150mmHg, diastolic blood pressure\>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ\~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF \<50%;
  • \. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption;
  • \. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
  • With coagulation abnormalities (PT\>16 s, APTT\>43 s, TT\>21 s, Fbg \<2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
  • \. Have a mental illness, or history of abuse of psychotropic substances;
  • \. With anastomotic recurrence and tracheal fistula;
  • \. Patients who participated in other drug clinical trials within 4 weeks;
  • \. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 600000, China

Location

MeSH Terms

Interventions

apatinibtyrosyl-glutamyl-tryptophanPlatinum

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Central Study Contacts

Daiyuan Ma

CONTACT

139 9088 9661mdylx@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

June 30, 2018

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

CN(1)