search
Back to results

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib,Paclitaxel,Cisplatin,RT
Sponsored by
Hebei Medical University Fourth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18 to 70 years old (man or female);
  2. Pathologically diagnosed with esophageal squamous cell carcinoma;
  3. Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography;
  4. Patients with measurable lesions(According to the criteria in RECIST1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  6. Life expectancy greater than or equal to 3 months;
  7. Major organ function has to meet the following certeria:

(1) For results of blood routine test

  1. HB≥80g/L;
  2. ANC≥1.5×109/L;
  3. PLT≥90×109/L; (2) For results of blood biochemical test

a) ALT and AST≤2.5×ULN; b) TBIL<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

  1. Have received prior treatment with chemotherapy or radiotherapy；
  2. Have high blood pressure and antihypertensive drug treatment can not control;
  3. Patients with severe cardiovascular disease ;
  4. Accompanied by esophageal perforation and esophagotracheal fistula;
  5. Patients with active bleeding or bleeding tendency;
  6. Pregnant or lactating women;
  7. The researchers think inappropriate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Apatinib+Paclitaxel+Cisplatin+RT

    Arm Description

    Apatinib：250mg,po,qd, d1-35; Paclitaxel：50mg/m2 iv, d1，8，15，22，29; Cisplatin: 30mg/m2 iv, d1，8，15，22，29; Radiotherapy：41.4Gy/23f , 1.8Gy/f，5 f/w

    Outcomes

    Primary Outcome Measures

    The pathological complete response rate(pCR)
    The lesion disappeared completely by pathology

    Secondary Outcome Measures

    R0-resection rate
    There was no residual by the microscope
    Disease-free survival(DFS)
    Baseline to measured date of recurrence or death from any cause
    Overall survival (OS)
    Baseline to measured date of death from any cause
    Adverse events Toxicity
    Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.

    Full Information

    First Posted
    February 26, 2019
    Last Updated
    February 26, 2019
    Sponsor
    Hebei Medical University Fourth Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03857763
    Brief Title
    A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
    Official Title
    A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    March 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hebei Medical University Fourth Hospital

    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
    The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Squamous Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apatinib+Paclitaxel+Cisplatin+RT
    Arm Type
    Experimental
    Arm Description
    Apatinib：250mg,po,qd, d1-35; Paclitaxel：50mg/m2 iv, d1，8，15，22，29; Cisplatin: 30mg/m2 iv, d1，8，15，22，29; Radiotherapy：41.4Gy/23f , 1.8Gy/f，5 f/w
    Intervention Type
    Combination Product
    Intervention Name(s)
    Apatinib,Paclitaxel,Cisplatin,RT
    Intervention Description
    Apatinib Mesylate Tablets 250mg qd p.o. d1-35; Paclitaxel：50mg/m2 iv d1，8，15，22，29; Cisplatin: 30mg/m2 iv d1，8，15，22，29; RT：41.4Gy/23f , 1.8Gy/f，5 f/w
    Primary Outcome Measure Information:
    Title
    The pathological complete response rate(pCR)
    Description
    The lesion disappeared completely by pathology
    Time Frame
    within 3 weeks after surgery
    Secondary Outcome Measure Information:
    Title
    R0-resection rate
    Description
    There was no residual by the microscope
    Time Frame
    within 3 weeks after surgery
    Title
    Disease-free survival(DFS)
    Description
    Baseline to measured date of recurrence or death from any cause
    Time Frame
    3 years
    Title
    Overall survival (OS)
    Description
    Baseline to measured date of death from any cause
    Time Frame
    1year
    Title
    Adverse events Toxicity
    Description
    Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age:18 to 70 years old (man or female); Pathologically diagnosed with esophageal squamous cell carcinoma; Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography; Patients with measurable lesions(According to the criteria in RECIST1.1); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Life expectancy greater than or equal to 3 months; Major organ function has to meet the following certeria: (1) For results of blood routine test HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; (2) For results of blood biochemical test a) ALT and AST≤2.5×ULN; b) TBIL<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. Exclusion Criteria: Have received prior treatment with chemotherapy or radiotherapy； Have high blood pressure and antihypertensive drug treatment can not control; Patients with severe cardiovascular disease ; Accompanied by esophageal perforation and esophagotracheal fistula; Patients with active bleeding or bleeding tendency; Pregnant or lactating women; The researchers think inappropriate.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

    We'll reach out to this number within 24 hrs