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Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
fluorouracil and platinum
Sponsored by
The First Affiliated Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, apatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.Male or female patients, age:≥18 years old.
  • 2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
  • 3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm).
  • 4.The ECOG physical status score: 0 to 2.
  • 5.Expected survival ≥ 3 months.
  • 6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
  • 7.The main organs function properly:

    1. blood routine examination standards to be met (14 days without blood transfusion and blood products):

      1. HB≥90g/L;
      2. ANC≥1.5×109/L;
      3. PLT≥80×109/L;
    2. biochemical tests to meet the following criteria:

      1. TBIL<1.5×ULN;
      2. ALT and AST<2.5×ULN, and <5×ULN for patients with liver metastases
      3. Serum Cr≤1.5×ULN or endogenous creatinine clearance> 45ml/min (Cockcroft-Gault formula);
  • 8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given;
  • 9.Patients should be voluntary to the trial and provide with signed informed consent

Exclusion Criteria:

  • 1.Pregnant or lactating women;
  • 2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function;
  • 3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;
  • 4.Coagulation dysfunction(INR>1.5 or prothrombin time (PT)>ULN + 4 seconds or APTT>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
  • 5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;
  • 6.Central nervous system metastasis with symptoms;
  • 7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study

Sites / Locations

  • First Affiliated Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apatinib with Chemotherapy

Chemotherapy

Arm Description

Apatinib with Chemotherapy(Fluorouracil and platinum),patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients

Chemotherapy (Fluorouracil and platinum),the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients.

Outcomes

Primary Outcome Measures

One-year survival rate
The probability of survival in one year

Secondary Outcome Measures

Progress free survival(PFS)
Overall survival
Incidence of Treatment-Emergent Adverse Events
Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment
Quality of life using EORTC QLQ C30 - scale
Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment

Full Information

First Posted
July 19, 2017
Last Updated
July 19, 2017
Sponsor
The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03224221
Brief Title
Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
Official Title
Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
January 23, 2019 (Anticipated)
Study Completion Date
June 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
Detailed Description
Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed. Apatinib, which was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer, is a small molecule tyrosine kinase inhibitor. It competes with intracellular VEGFR-2's ATP binding sites highly and selectively, thereby blocking downstream signaling to achieve the goal of inhibiting neovascularization in tumor tissue. We have observed in clinical practice that some patients with esophageal squamous cell carcinoma have benefited from the treatment of apatinib. So we conduct a phase II clinical trial to explore the efficacy and safety of Apatinib combined with chemotherapy (platinum and fluorouracil) in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, apatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib with Chemotherapy
Arm Type
Experimental
Arm Description
Apatinib with Chemotherapy(Fluorouracil and platinum),patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy (Fluorouracil and platinum),the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Patients will receive Apatinib at 500mg/times,oral one times daily for 28 days
Intervention Type
Drug
Intervention Name(s)
fluorouracil and platinum
Intervention Description
the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
Primary Outcome Measure Information:
Title
One-year survival rate
Description
The probability of survival in one year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progress free survival(PFS)
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Title
Overall survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment
Time Frame
Each follow up visit, assessed up to 12 months
Title
Quality of life using EORTC QLQ C30 - scale
Description
Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Male or female patients, age:≥18 years old. 2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma. 3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm). 4.The ECOG physical status score: 0 to 2. 5.Expected survival ≥ 3 months. 6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed; 7.The main organs function properly: blood routine examination standards to be met (14 days without blood transfusion and blood products): HB≥90g/L; ANC≥1.5×109/L; PLT≥80×109/L; biochemical tests to meet the following criteria: TBIL<1.5×ULN; ALT and AST<2.5×ULN, and <5×ULN for patients with liver metastases Serum Cr≤1.5×ULN or endogenous creatinine clearance> 45ml/min (Cockcroft-Gault formula); 8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given; 9.Patients should be voluntary to the trial and provide with signed informed consent Exclusion Criteria: 1.Pregnant or lactating women; 2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function; 3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction; 4.Coagulation dysfunction(INR>1.5 or prothrombin time (PT)>ULN + 4 seconds or APTT>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding; 6.Central nervous system metastasis with symptoms; 7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoping Sun, Ph.D.
Phone
0551-62922249
Email
gpsun_ahmu@126.com
Facility Information:
Facility Name
First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Sun
Phone
0551-62922249
Email
gpsun_ahmu@126.com

12. IPD Sharing Statement

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Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment

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