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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Combination Product: Apatinib,Paclitaxel,Cisplatin,RT

• Registration Number: NCT03857763
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Study First Posted: 2019-02-28
• Last Update Posted: 2019-02-28
• Study Start: 2019-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib+Paclitaxel+Cisplatin+RT	Apatinib,Paclitaxel,Cisplatin,RT	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

Primary Outcome Measures

Name	Time	Method
The pathological complete response rate(pCR)	within 3 weeks after surgery	The lesion disappeared completely by pathology

Secondary Outcome Measures

Name	Time	Method
Disease-free survival(DFS)	3 years	Baseline to measured date of recurrence or death from any cause
Adverse events Toxicity	3 years	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.
Overall survival (OS)	1year	Baseline to measured date of death from any cause
R0-resection rate	within 3 weeks after surgery	There was no residual by the microscope