Status:
UNKNOWN
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03857763
Start Date
March 1 2019
End Date
March 1 2023
Last Update
February 28 2019
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