Adjuvant Immunotherapy for Esophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University

About this trial

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.

Eligibility criteria

Qualifiers

Aged ≥18 years.

Histologically confirmed esophageal squamous cell carcinoma.

Preoperative staging of cT1b-cT2N+M0 or cT3-cT4a, any N, M0 (UICC/AJCC TNM staging, 8th edition, 2017), and treated with neoadjuvant therapy using an immunotherapy combined with a taxane and platinum regimen, followed by radical surgical resection.

R0 resection.

Disqualifiers

Presence of blood-borne infectious disease human immunodeficiency virus (HIV).

Presence of psychiatric disorders.

History of any other malignancy within the past 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin).

Treatment in the ICU due to severe complications after radical surgery for esophageal cancer.

Trial design

Treatments tested in this trial

  • Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab)
  • Observation

Treatment groups

98 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators