Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas (NCT06654297) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas
China6 participantsStarted 2024-10-27
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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.…
What they're measuring
1
Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events
Timeframe: up to 15 weeks
2
Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events