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

Hebei Medical University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: Apatinib,Paclitaxel,Cisplatin,RT

Study type: Interventional

Funder types: Other

Identifiers

NCT03857763

HBAE-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Apatinib+Paclitaxel+Cisplatin+RT

Experimental group

Description:

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

Treatment:

Combination Product: Apatinib,Paclitaxel,Cisplatin,RT