This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma
This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma. In this study, patients are 1:1 randomized to either the study group or the control group. Patients in the study group will receive apatinib during induction immuno-chemotherapy and concurrent chemoradiotherapy. Patients in the control group will receive induction immuno-chemotherapy and concurrent chemoradiotherapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Toripalimab 240mg iv. drip, Q3W, 2 cycles
Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.
Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progression free survival rate
From the first day of treatment to the day of progression or the day of death.
Time frame: 1 year
Overall survival
It was calculated from the first day of treatment to the day of death.
Time frame: 1 year
Objective response rate
The proportion of patients evaluated as CR or PR
Time frame: 1 year
Local-regional progression-free survival
Local-regional progression-free survival refers to the period from the initiation of treatment until the occurrence of progression in the primary site or locoregional lymph node regions.
Time frame: 1 year
Incidence of Treatment-related Adverse Events
Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on.
Time frame: 1 year
Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer)
The evaluation of life quality
Time frame: 1 year
Distant metastasis-free survival
Distant metastasis-free survival refers to the period from the initiation of treatment until the appearance of metastasis in distant organs or tissues.
Time frame: 1 year
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Oral apatinib 250mg once daily during induction therapy and concurrent chemoradiotherapy.
Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy