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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT03857763
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib,Paclitaxel,Cisplatin,RT — 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

Study Details

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.

Key Dates

Start date
Mar 1, 2019
Status verified
Feb 2019
Primary completion
Mar 1, 2020
Completion
Mar 1, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

The pathological complete response rate(pCR) [ Time Frame: within 3 weeks after surgery ]

Related Studies