Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Sichuan University

Status and phase: Enrolling; Phase 1

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Camrelizumab; Drug: Palbociclib(100mg); Drug: Palbociclib(125mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT06654297

2023-1551-E

Details and patient eligibility

About

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).

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Camrelizumab+Palbociclib(100mg) 3 patients

Experimental group

Description:

For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.

Treatment:

Drug: Palbociclib(100mg)

Drug: Camrelizumab

Camrelizumab+Palbociclib(125mg) 3 patients

Experimental group

Description:

For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.

Treatment:

Drug: Palbociclib(125mg)

Drug: Camrelizumab