Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Официальное название

A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Обзор

Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles, with no adverse reactions of grade 3 or higher. The trial reported a major pathological response (MPR) rate of 24%, a pathological complete response (pCR) rate of 8%, a 2-year overall survival (OS) rate of 92%, and a 2-year recurrence-free survival (RFS) rate of 100%. The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain. This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC.

Вмешательства

• Препарат Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib
  Adbelimumab 1200mg Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Apatinib 250mg Po Day 2-4. Preoperative neoadjuvant therapy for 4 cycles, one cycle every 21 days.
• Процедура Esophagectomy
  Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive IvorLewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy. The surgeries will be perf
• Другое Collecting samples from participant
  Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 20 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 after surgery.

Первичные конечные точки

• Pathological Complete Response (PCR) [Срок оценки: 1 month after surgery]

Вторичные конечные точки (6)

• Major Pathological Response (MPR) [Срок оценки: 1 month after surgery]
• Objective Response Rate (ORR) [Срок оценки: before surgery]
• The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients [Срок оценки: 3 months after surgery]
• 2-year and 5-year overall survival [Срок оценки: 2-year and 5-year after enrolled]
• Incidence of Treatment-related Adverse Events [Срок оценки: 1 month after surgery]
• R0 resection rate [Срок оценки: 1 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: NCT06576973 · 2024-0949

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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