NCT07374003

Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced, Resectable

Interventions

Type	Name	Description
DRUG	lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin	1. Ipromlimab and Tuvonralimab Dosage: 5 mg/kg, intravenous drip, Day 1, every 3 weeks 2. Albumin-Bound Paclitaxel Dosage: 260 mg/m², intravenous drip, Day 1, every 3 weeks 3. Nedaplatin Dosage: 75 mg/m², intravenous drip, Day 1, every 3 weeks Treatment Scheme: 1. Neoadjuvant Therapy (2-4 cycles): Patients receive study drugs Q3W. Response is assessed after 2 cycles to decide on continuing to 4 cycles or proceeding to surgery. 2. Surgery: Radical esophagectomy is performed within 4-6 weeks post-neoadjuvant therapy. 3. Postoperative Management: pCR with R0 resection: Observation. Non-pCR with R0 resection: Adjuvant therapy. Non-R0 resection: Treatment per MDT decision

Timeline

• Start date: 2025-12-17
• Primary completion: 2029-06-20
• Completion: 2029-12-20
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China