Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Phase 1Active Not RecruitingNCT06654297

West China Hospital6 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

CamrelizumabDRUG

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.

Palbociclib(100mg)DRUG

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 three cycles.

Palbociclib(125mg)DRUG

Palbociclib will be given at a dose of 125 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events

Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Time frame: up to 15 weeks

Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events

Patients proceed to surgery without experiencing prolonged treatment-related delays. An extended treatment-related delay will be considered if it exceeds 37 days from the initially scheduled surgery date. In terms of feasibility, if there is any treatment toxicity of any grade that could adversely impact prognosis, as judged by the investigators, the planned operative date should be re-evaluated.

Time frame: up to 15 weeks

Secondary Outcomes

Major Pathologic Response

Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.

Time frame: up to 15 weeks

Objective response rate (ORR)

Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of camrelizumab and palbociclib

Time frame: up to 15 weeks

Progression free survival(PFS)

Proportion of participants who achieve progression free survival post treatment

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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