Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07374003
PHASE2

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2025-12-17

Completion Date

2029-12-20

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

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

Locations (1)

Sub-i

Guangdong, GUANGZHOU, China