Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT07067450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Immunotherapy for Esophageal Squamous Cell Carcinoma
Sponsor:
Sichuan University
Organization:
Study Overview
Official Title:
Adjuvant Immunotherapy Versus Observation Following Neoadjuvant Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: