Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC

Sponsor
Sun Yat-sen University
Study ID
NCT07177794
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • toripalimab — DRUG
    Patients will receive toripalimab with a maximum treatment duration of one year (240 mg, IV drip, Q3W, for 16 cycles).
  • capecitabine — DRUG
    Patients will receive metronomic capecitabine, with a maximum treatment duration of one year (500 mg, twice daily, orally).

Study Details

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.

Key Dates

First listed
Sep 17, 2025
Start date
Sep 10, 2025
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Patients will receive toripalimab combined with metronomic capecitabine, with a maximum treatment duration of one year (toripalimab 240 mg, IV drip, Q3W, for 16 cycles; capecitabine 500 mg, twice daily, orally).
  • No Intervention: Arm B
    Patients will undergo conventional observation and follow-up.

Primary Outcome Measure

Progression-free survival [ 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 ]

Central Contacts

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