Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

Официальное название

Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial

Обзор

The goal of this Phase 2 clinical trial is to learn if the combination of Camrelizumab and Palbociclib is a safe and effective treatment when given before surgery (neoadjuvant therapy) for patients with esophageal squamous cell carcinoma (ESCC) that can be surgically removed. Camrelizumab is an immunotherapy drug that helps the immune system fight cancer, and Palbociclib is a targeted therapy drug that stops cancer cells from growing. The main questions it aims to answer are: Is the combination of Camrelizumab and Palbociclib safe for patients to receive before their surgery? How effective is this treatment combination in shrinking tumors prior to surgery?

Вмешательства

• Препарат Camrelizumab
  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.
• Препарат Palbociclib
  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.

Первичные конечные точки

• Major Pathologic Response [Срок оценки: up to 15 weeks]

Вторичные конечные точки (5)

• Pathological Complete Response (PCR) [Срок оценки: up to 15 weeks]
• Overall survival (OS) [Срок оценки: Up to 2 years]
• Objective response rate (ORR) [Срок оценки: up to 15 weeks]
• R0 resection rate [Срок оценки: up to 15 weeks]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: from the first dose to within 30 days after the last dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07191977 · 2025-417

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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