Search / Trial NCT06225921

Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

Launched by WEST CHINA HOSPITAL · Jan 25, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Esophageal Squamous Cell Carcinoma Neoadjuvant Therapy Immunotherapy Cdk4/6 Inhibitor

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of throat cancer called esophageal squamous cell carcinoma (ESCC) that can be surgically removed. The trial is testing a combination of two drugs: Adebrelimab, which is an immunotherapy that helps the body’s immune system fight cancer, and Dalpiciclib, which works by blocking certain cell functions that help cancer grow. The goal is to see if this combination is safe and effective before surgery.

To participate in this trial, patients need to be between 18 and 75 years old and have been diagnosed with ESCC that is located in the chest area. Patients will be asked to understand the study and agree to surgical treatment. However, individuals with more advanced cancer that cannot be surgically removed, those currently receiving other cancer treatments, or those with certain medical conditions, among other criteria, may not be eligible. Participants in the trial can expect to receive the treatment and be closely monitored for their health and any side effects. This research is important as it may lead to better treatment options for patients with this type of cancer.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Jin Zhou, MD.,PhD.

Principal Investigator

West China Hospital

About West China Hospital

West China Hospital, affiliated with Sichuan University, is a leading medical institution renowned for its comprehensive healthcare services, advanced research initiatives, and commitment to medical education. As a prominent clinical trial sponsor, the hospital leverages its extensive resources and expertise to facilitate innovative research in various therapeutic areas. With a focus on improving patient outcomes and advancing medical knowledge, West China Hospital collaborates with various stakeholders to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. Its state-of-the-art facilities and multidisciplinary teams ensure the successful execution of trials, contributing significantly to the global healthcare landscape.

Locations

Chengdu, Sichuan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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