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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03857763
• Other study ID #: HBAE-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2019
• Source: Hebei Medical University Fourth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?-?(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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Combination Product:
• Apatinib,Paclitaxel,Cisplatin,RT
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathological complete response rate(pCR)	The lesion disappeared completely by pathology	within 3 weeks after surgery
Secondary	R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Secondary	Disease-free survival(DFS)	Baseline to measured date of recurrence or death from any cause	3 years
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	1year
Secondary	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.	3 years