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

NCT ID: NCT03857763

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-03-01

Brief Summary

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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

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Apatinib,Paclitaxel,Cisplatin,RT

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Fourth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HBAE-01

Identifier Type: -

Identifier Source: org_study_id