Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

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

Inclusion Criteria:

1. 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 .
2. The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
3. The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.

Exclusion Criteria:

1. The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.
2. Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.
3. History of other malignancies.
4. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
5. Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
6. Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.
7. 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.
8. 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.
9. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
10. Any other factors that are not suitable for inclusion in this study judged by investigators.

Conditions2

Interventions3

Related trials

• A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC) — Tianjin Medical University Cancer Institute and Hospital
• A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer — Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
• A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC — Nanfang Hospital, Southern Medical University
• A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC — Zeng Jian
• A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer — Jin Ying
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma — The First Affiliated Hospital of Xiamen University
• A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer — Shanghai Hengrui Pharmaceutical Co., Ltd.

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