Trial intelligence / Profile preview

Cadonilimab plus Anlotinib Neoadjuvant Therapy for ESCC

NCT06426797Phase 2

Key facts

Status
Not yet recruiting
Start
May 2024
Primary completion
May 2025
Sponsor
Peking University People's Hospital
Modality
Bispecific Antibodies
Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
01

Overview

Phase 2, open-label, single-arm trial of cadonilimab in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Peking University People's Hospital. Primary endpoint: Pathological Complete Response Rate. Planned start May 2024; status: not yet recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Cadonilimab + Anlotinib

    Patients receive Cadonilimab and Anlotinib for 3 cycles followed by surgery.

03

Who it enrols

Patients with locally advanced resectable esophageal squamous cell carcinoma (T1-2N1-3M0, T2>=3cm N0M0, or T3-4aN0-3M0), ECOG 0-2, and adequate organ function. Excludes prior chemotherapy/radiotherapy for esophageal cancer, prior immune checkpoint inhibitors, active autoimmune disease, and severe cardiovascular conditions.

04

Endpoints

Primary

  • Pathological Complete Response Rate

Secondary

  • Major Pathological Response Rate

  • Objective Response Rate

  • Treatment Emergent Adverse Events

  • Event-free Survival

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