Combining Camrelizumab and Palbociclib for Esophageal Cancer Treatment
The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
This study is testing if combining two drugs, Camrelizumab and Palbociclib, can safely help people with esophageal cancer before they have surgery.
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, Camrelizumab |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06654297 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of using Camrelizumab, an anti-PD-1 immunotherapy, in combination with Palbociclib, a cyclin-dependent kinase 4/6 inhibitor, as a neoadjuvant treatment for patients with resectable esophageal squamous cell carcinoma (ESCC). The trial aims to evaluate how well this combination works before surgical intervention. Patients will be closely monitored for safety and treatment response throughout the process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with resectable esophageal squamous cell carcinoma and no significant organ dysfunction.
Not a fit: Patients with unresectable tumors, those undergoing other cancer treatments, or those with severe autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with esophageal squamous cell carcinoma by enhancing tumor response prior to surgery.
How similar studies have performed: While the combination of immunotherapy and targeted therapy is being explored in various cancers, this specific approach for esophageal squamous cell carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 etc. 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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Jin Zhou
- Email: zhoujin096@scu.edu.cn
- Phone: 13880626596
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.