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Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 1, 2026 → Dec 1, 2026
See other at-risk trials from Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record History

  1. Enrollment reopened Primary completion pushed from Jul 1, 2026 to Dec 1, 2026 · Study sites: 9 to 10 · Eligibility criteria expanded, about 46 words · 1 more Show 4 more changesShow less
    • Primary completion pushed from Jul 1, 2026 to Dec 1, 2026
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 46 words
    • Publications: details revised at 10 of 10 entries
  2. Eligibility criteria expanded, about 6 words Study description expanded, about 10 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  3. Interventions: Sintilimab + radiotherapy + enteral nutritional emulsion (TPF-T) (Combination Product) to Immunonutrition support (Dietary Supplement), Programmed Cell Death Protein 1 Inhibitor (Drug), Radiotherapy (Radiation) Secondary endpoints: details revised at 3 of 5 entries · Study description shortened, about 177 words · Study sites revised (9) · 1 morev2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description shortened, about 177 words
    • Study sites revised (9)
    • Study title shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.
Trial Details
NCT Number NCT06342167
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Locally Advanced Esophageal Squamous Cell Carcinoma, Sintilimab, Radiotherapy, Concurrent Chemoradiotherapy, Immunonutrition
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov