Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Официальное название

A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of the Combination of Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Обзор

In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.

Подробное описание

In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. The high risk of local recurrence and distant metastasis, which affect patient prognosis and survival rates. Preoperative immunotherapy holds the potential to activate the patient's immune system to recognize tumor antigens and establish immune memory, thereby enabling the immune system to maintain its surveillance role following surgical tumor resection. Consequently, there is a growing emphasis on the administration of immunotherapy prior to surgery across various solid tumor types.

Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. However, a substantial subset of patients either responds inadequately or develops resistance to these therapies. To address this challenge, numerous combination treatment strategies have been explored in clinical research. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. Notably, there is a paucity of research regarding the combination of camrelizumab with chemotherapy and Ivarmacitinib as a neoadjuvant therapy. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.

Вмешательства

• Комбинированный продукт Camrelizumab, Chemotherapy and Ivarmacitinib
  The treatment regimen includes the administration of Camrelizumab at a dose of 200 mg, Paclitaxel (albumin-bound) at 260 mg/m², and Carboplatin with an area under the curve (AUC) of 5. These medications are administered every 3 weeks for a total of 3 cycles. Additionally, Ivarmacitinib tablets are administered orally at a dosage of 4 mg daily during the first and second cycles, but are omitted during the third cycle, totaling 42 days of administration.
• Процедура Esophagectomy
  Prior to each surgical procedure, the department engaged in comprehensive discussions to determine and establish the most appropriate course of action. Depending on the tumor location, a minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two-field extensive lymphadenectomies, was performed. The resection length was required to be at least 5 cm from the tumor origin, as determined by pre-chemotherapy endoscopy. These surgeries were con
• Другое Sample
  Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery. Tumour sample will be collected before neoadjuvant therapy and during surgery.

Первичные конечные точки

• Rate of pathological complete response (PCR) [Срок оценки: 1 month after surgery]

Вторичные конечные точки (5)

• Rate of major pathological response (MPR) [Срок оценки: 1 month after surgery]
• Rate of objective response rate (ORR) [Срок оценки: before surgery]]
• 2-year and 5-year event free survival (EFS) [Срок оценки: 2-year and 5-year after enrolled]
• Incidence of Treatment-related Adverse Events [Срок оценки: 1 month after surgery]
• The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients [Срок оценки: 3 month after surgery]

Критерии участия

Критерии включения

• signed informed consent;
• patients age 18 to 75 years old
• primary resectable, histologically confirmed esophageal squamous cell cancer;
• Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
• ECOG PS 0-1.
• No distant metastasis, the diseases could be resectable assessed by thoracic oncologist．

Критерии исключения

• with significant cardiovascular disease;
• current treatment with anti-viral therapy or HBV;
• Female patients who are pregnant or lactating;
• history of malignancy within 5 years prior to screening;
• active or history of autoimmune disease or immune deficiency;
• signs of distant metastases.

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

Китай · 1 центр

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07505186 · 2026-0379

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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