This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma. All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Toripalimab 240 mg, d1, Q3w for two cycles
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
Nedaplatin 75mg/m2, d1, Q3w for two cycles
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
progression-free survival rate
Time frame: 18-month
overall survival rate
Time frame: 18-month
Clinical response rate
the percentage of patients who had partial remission or complete remission after therapy
Time frame: 2 months after radiotherapy
the rate of grade 3 or 4 toxicities according to CTCAE4.0
the percentage of patients who develop grade 3 or 4 toxicities
Time frame: 1 year after therapy
distant metastasis-free survival
Time frame: 18-month
locoregional recurrence-free survival
Time frame: 18-month
Quality of life assessed by QLQ-C30
Time frame: 12 months
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Radiation therapy at a total dose 60 Gy
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
Radiation therapy at a total dose 50 Gy