Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

Официальное название

A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

Обзор

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

Подробное описание

This study is a prospective, single center, open label, single arm Phase II clinical study. Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study, who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was performed. The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed, with pCR and MPR as the main research endpoints.

Вмешательства

• Препарат Combination of pembrolizumab and platinum containing dual drugs
  After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery

Первичные конечные точки

• Pathological complete remission (pCR) [Срок оценки: in two weeks after the surgical resection]

Вторичные конечные точки (5)

• Major pathological remission (MPR) [Срок оценки: in two weeks after the surgical resection]
• R0 resection rate [Срок оценки: in two weeks after the surgical resection]
• Progression free survival (PFS) [Срок оценки: receiving therapy，up to approximately 2years.]
• Total survival time (OS) [Срок оценки: The time from the patient's randomization receiving therapy to death from any cause，up to approximately 2years]
• Safety (incidence of adverse drug reactions) [Срок оценки: Randomly group patients to receive treatment for up to two years]

Критерии участия

Критерии включения

• Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
• Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
• Age range from 18 to 75 years old;
• There are no surgical contraindications in the preoperative evaluation of various organ functions;
• The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value;
• Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years;
• Expected to achieve R0 resection;
• Physical state ECOG 0-1;
• The subjects must understand and sign the informed consent form

Критерии исключения

• Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
• Not suitable for surgery or with surgical contraindications;
• Have a history of other anti PD-L1/PD-1 treatments;
• Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
• Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
• Patients with poor control of heart disease
• Pregnant or lactating female patients;
• For patients with drug allergies in the protocol.

Exit criteria：

Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment:

• The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
• The surgical procedure violates the plan;
• Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics;
• According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
• Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported together;
• Missing subjects. All subjects who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival analysis and toxicity evaluation for the corresponding group.

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

• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT06304350 · SGHDOT-24-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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