NCT06654297Active, not recruitingPhase 1
Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas
The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 20 Jul 2024
- Start date
- 27 Oct 2024
- Primary completion date
- 3 Jun 2025
- Lead sponsor
- West China Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06654297
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From 27 Oct 2024 to the primary completion date, 3 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.
- Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
Other illness
- The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.
- 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.
Lab values
- 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.
Other
- Any other factors that are not suitable for inclusion in this study judged by investigators.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.