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

NCT07374003 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Locally Advanced, Resectable

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2029-06-20
Completion
2029-12-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374003 on ClinicalTrials.gov