Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Trial Title: Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

NCT ID: NCT06654297

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Palbociclib

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab
Description: Camrelizumab will be given at at a dose of 200 mg intravenously on day 23 of a planned 28-day cycle, and two doses before surgery.
Arm group label: Camrelizumab+Palbociclib(100mg) 3 patients
Arm group label: Camrelizumab+Palbociclib(150mg) 3 patients

Intervention type: Drug
Intervention name: Palbociclib(100mg)
Description: Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Arm group label: Camrelizumab+Palbociclib(100mg) 3 patients

Intervention type: Drug
Intervention name: Palbociclib(150mg)
Description: Palbociclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Arm group label: Camrelizumab+Palbociclib(150mg) 3 patients

Summary: he 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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 . - 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 test indices should meet the following requirements: - Blood：White blood cell count (WBC) > 4.0 * 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 * 10^9/L; Platelet count (PLT) > 100 * 10^9/L; Hemoglobin (HBG) > 90 g/L; - Pulmonary Function: Forced Expiratory Volume in the first second (FEV1) ≥ 1.2 L; FEV1% ≥ 50%; Carbon monoxide diffusing capacity (DLCO) ≥ 50% - Liver Function: Serum bilirubin should be lower than 1.5 times the maximum normal value; Alanine aminotransferase (ALT) and Aspartate transaminase (AST) should be lower than 1.5 times the maximum normal value; - Renal Function; Serum creatinine (SCr) ≤ 120 μmol/L; Creatinine clearance rate (CCr) ≥ 60 ml/min. - 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.The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Recruiting

Contact:
Last name: Jin Zhou, MD.,PhD.

Phone: +8613880626596
Email: zhoujin096@scu.edu.cn

Contact backup:
Last name: Shangwei Sun

Phone: +8615291996883
Email: sunshangwei@stu.scu.edu.cn

Start date: October 31, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: West China Hospital
Agency class: Other

Source: West China Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06654297