RecruitingPhase 1NCT06225921

Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial

Sponsor

West China Hospital

Enrollment

6 participants

Start Date

Dec 29, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.
The primary tumor should be located in the thorax.
The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations .
The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.

Exclusion Criteria10

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 autoimmune disease.
Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.
The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy, are excluded from the study.
Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded.
Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
Any other factors that are not suitable for inclusion in this study judged by investigators.

Interventions

DRUGDalpiciclib 150mg

Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

DRUGAdebrelimab

Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.

DRUGDalpiciclib 100mg

Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.