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
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
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.
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
NCT ID
NCT03857763
First Posted
February 26, 2019
Last Updated
February 26, 2019
Sponsor
Hebei Medical University Fourth Hospital
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
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