Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:11 AM
Study NCT ID:
NCT07374003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Phase II, Single-Arm Clinical Study of Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
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:
This is a Phase II, single-arm clinical study designed to evaluate the efficacy and safety of Ipromlimab combined with Tuvonralimab, plus Albumin-Bound Paclitaxel and Nedaplatin, as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Detailed Description:
Eligible patients will receive 2-4 cycles of the combined neoadjuvant therapy (administered every 3 weeks), with response assessed after 2 cycles to determine whether to continue to 4 cycles or proceed to radical esophagectomy. Postoperative management will be tailored based on pathological results: observation for patients achieving pathological complete response (pCR) with R0 resection, adjuvant therapy for non-pCR with R0 resection, and treatment per multidisciplinary team (MDT) decision for non-R0 resection. The primary objective is to assess the pathological complete response (pCR) rate, and secondary objectives include evaluating objective response rate (ORR), disease control rate (DCR), major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS), 3-year disease-free survival rate, overall survival (OS), and safety profile. Exploratory objectives involve identifying predictive biomarkers for neoadjuvant immunotherapy response through multi-omics analysis of biological samples. This study aims to provide evidence for optimizing neoadjuvant treatment strategies in locally advanced resectable esophageal squamous cell carcinoma.
Study Oversight
Has Oversight DMC:
False
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?: