Clinical trial NCT06654297: Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas
Official title: The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events
timeFrame: up to 15 weeks
measure: Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events
timeFrame: up to 15 weeks
Secondary outcomes:
measure: Maximum Tolerated Dose (MTD) of palbociclib as determined by number of participants with dose limiting toxicities (DLT)
timeFrame: up to 15 weeks
measure: Major Pathologic Response
timeFrame: up to 15 weeks
measure: Objective response rate (ORR)
timeFrame: up to 15 weeks
measure: Progression free survival(PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
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