Adjuvant Immunotherapy for Esophageal Squamous Cell Carcinoma

Sponsor
Sichuan University
Study ID
NCT07067450
Status
Not Yet Recruiting

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Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients with esophageal cancer still face a high risk of recurrence after receiving neoadjuvant chemoradiotherapy (nCRT) combined with radical surgery, especially for those who do not achieve pathological complete response (non-pCR). Compared with the overall non-pCR population, the subgroup with lymph node positivity has a significantly worse prognosis. The CheckMate 577 study confirmed that in patients with locally advanced resectable esophageal cancer or esophageal-gastric junction cancer, adjuvant treatment with nivolumab after nCRT significantly prolonged disease-free survival compared with placebo (median DFS: 22.4 months vs 11.0 months; HR=0.69, p\<0.001). The current research focus has expanded to the field of neoadjuvant chemoimmunotherapy, but the adjuvant treatment strategy after such therapy remains a blank slate. Given that esophageal squamous cell carcinoma (ESCC) is the predominant type of esophageal cancer in our country, it is of great clinical significance to explore adjuvant treatment strategies after neoadjuvant chemoimmunotherapy combined with radical resection. Based on the above background, we have designed a randomized controlled trial (RCT) to evaluate the efficacy of adjuvant immunotherapy versus observation alone in patients with ESCC after neoadjuvant chemoimmunotherapy, with the hope of providing evidence-based medical evidence for this population.

Key Dates

Start date
Jul 20, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Adjuvant Immunotherapy Group
    For patients with non-pCR esophageal squamous cell carcinoma after neoadjuvant chemoimmunotherapy, adjuvant immunotherapy with immune checkpoint inhibitors (the same ICIs used before surgery) is administered postoperatively, once every three weeks, for a total of 15 treatments.
  • Active Comparator: Observation Group
    For patients with non-pCR esophageal squamous cell carcinoma after neoadjuvant chemoimmunotherapy, postoperative observation is conducted without the use of any anti-tumor treatment.

Primary Outcome Measure

Disease-Free Survival (DFS) [ Time Frame: From the time of patient enrollment, up to a maximum of 2 years. ]

Central Contacts

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