A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2019
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFebruary 28, 2019
February 1, 2019
1 year
February 26, 2019
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The pathological complete response rate(pCR)
The lesion disappeared completely by pathology
within 3 weeks after surgery
Secondary Outcomes (4)
R0-resection rate
within 3 weeks after surgery
Disease-free survival(DFS)
3 years
Overall survival (OS)
1year
Adverse events Toxicity
3 years
Study Arms (1)
Apatinib+Paclitaxel+Cisplatin+RT
EXPERIMENTALApatinib：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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
March 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2023
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share