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Recruiting Phase 1 NCT06654297

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Trial Parameters

Condition Esophageal Squamous Cell Carcinoma
Sponsor West China Hospital
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 6
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-08-04
Completion 2025-10-31
Interventions
CamrelizumabPalbociclib(100mg)Palbociclib(125mg)

Brief Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Eligibility Criteria

Inclusion Criteria: * Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies. * The primary tumor should be located in the thorax and evaluated resectable( cT1b-T3N1-3M0, cT3N0M0) by CT/MRI/EUS * The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1. * The patients should have no functional disorders in major organs. Blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal. * The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent. Exclusion Criteria: * The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected. * Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy. * History of other malignancies. * Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoim

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