Combination of Adebrelimab and Dalpiciclib for Esophageal Cancer Treatment
The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
This study is testing if a new combination of two drugs can help people with esophageal cancer before they have surgery to remove the tumor.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Adebrelimab |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06225921 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of using Adebrelimab, an anti-PD-L1 immunotherapy, in combination with Dalpiciclib, a CDK4/6 inhibitor, as a neoadjuvant treatment for patients with resectable esophageal squamous cell carcinoma (ESCC). The goal is to determine how well this combination works before surgical resection of the tumor. Patients will be closely monitored for safety and treatment response during the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with resectable esophageal squamous cell carcinoma located in the thorax.
Not a fit: Patients with advanced stage tumors that cannot be resected or those currently undergoing other cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with esophageal squamous cell carcinoma.
How similar studies have performed: While the combination of immunotherapy and CDK4/6 inhibitors is a novel approach, similar studies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Jin Zhou, MD.,PhD. — West China Hospital
- Study coordinator: Jin Zhou, MD.,PhD.
- Email: zhoujin096@scu.edu.cn
- Phone: +8613880626596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.