Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Patients will receive toripalimab with a maximum treatment duration of one year (240 mg, IV drip, Q3W, for 16 cycles).
Patients will receive metronomic capecitabine, with a maximum treatment duration of one year (500 mg, twice daily, orally).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months
Overall survival
Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months
Clinical complete response
Tumor response was evaluated 14-16 weeks after the completion of radiotherapy based on CT or PET-CT scans, and endoscopy with biopsies.
Time frame: 14-16 weeks after the completion of radiotherapy
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
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