CClinicalTrials.gg
Status unknownNCT03170310Updated May 31, 2017

Apatinib Treatment for Advanced Esophagus Cancer

A Phase 2 interventional study of Apatinib in Advanced Esophagus Cancer, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2017, registered May 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.

02

Conditions studied

  • Advanced Esophagus Cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age: 18 to 75 years old, men and women;
    1. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
    1. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
    1. ECOG PS:0-1;
    1. Life expectancy≥12 weeks;
    1. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
    1. The main organs function properly, that is, meet the following criteria:

      1. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
      2. biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST\<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
    1. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
    1. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
    1. Investigator believe that subject who can benefit.

Exclusion criteria

Exclusion Criteria:

    1. In the past or at the same time with suffered from other malignancies;
    1. Pregnant or lactating women;
    1. 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%;
    1. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorption;
    1. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
    1. Central nervous system metastasis has occurred;
    1. With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg\<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
    1. With mental illness, or mental history of drug abuse;
    1. With anastomotic recurrence;
    1. Patients who have participated in other drug clinical trials in 4 weeks;
    1. 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;
    1. Patients those researchers believe not suitable for the inclusion.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Apatinib

    Drug: Apatinib

Interventions

  • DrugApatinib

    Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.

06

What researchers measure

Primary outcomes

  1. Progress free survival

    Time subject into the group to tumor objective progression.

    Time frame: 24 months

Secondary outcomes

  1. Overall survival

    Time subject into the group to die.

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
    ZhengZhou, Henan 450008, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03170310
Lead sponsor
Henan Cancer Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 31, 2017
Start date
Feb 21, 2017
Primary completion
Feb 21, 2019 (estimated)
Completion
Sep 21, 2019 (estimated)
Last update
May 31, 2017

Study contacts

Ying Liu
Contact
yaya7207@126.com
13783604602

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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