Immune checkpoint inhibitor therapy combined with
chemotherapy is safe and effective in treating advanced esophageal
carcinoma; however, some patients still experience
tumor progression and/or
metastasis. Whether the addition of
radiotherapy to
immunotherapy combined with
chemotherapy improves the prognosis of patients with advanced/metastatic esophageal
carcinoma needs to be investigated. In the present study, we developed a protocol for our clinical trial indicating that
toripalimab combined with
induction chemotherapy followed by
chemoradiotherapy can safely prolong survival in patients with stage IV esophageal
carcinoma. This open-label, single-arm, phase II trial will include patients with unresectable stage IV
esophageal squamous cell carcinoma who have not received prior systemic
therapy. The patients will be treated with two cycles of
toripalimab (240 mg, 1 day before
chemotherapy, Q3W) combined with
induction chemotherapy (
paclitaxel, 135-175 mg/m2 +
carboplatin, area under the curve = 4-6, day 1, intravenous, Q3W). Thereafter, they will undergo two cycles of the aforementioned treatment with concurrent
radiotherapy (30-50 Gy in 15-25 fractions), followed by
toripalimab (240 mg, day 1, Q3W) for 1 year. The primary outcome measure will be progression-free survival; the secondary outcome measures will include the objective response rate, disease control rate, duration of remission, 1- and 2-year overall survival rates, safety and tolerability, and changes in health-related quality of life. The study protocol was approved by the Ethics Committee of Sichuan Cancer Hospital (SCCHEC-02-2021-021). The trial is underway in accordance with the Declaration of Helsinki.
Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=126830, identifier ChiCTR2100046715.