新辅助放化疗联合替雷利珠单抗治疗食管癌（CRISEC 研究）：一项前瞻性、单臂、Ⅱ期临床试验方案。
Neoadjuvant chemoradiotherapy plus tislelizumab followed by surgery for esophageal carcinoma (CRISEC study): the protocol of a prospective, single-arm, phase II trial.
机构信息
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430023, China.
Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
出版信息
BMC Cancer. 2023 Mar 15;23(1):249. doi: 10.1186/s12885-023-10687-8.
BACKGROUND
The failure rate after neoadjuvant chemoradiotherapy followed by surgery is approximately 34.6%-48% for resectable esophageal carcinoma. Pathologic complete response after neoadjuvant chemoradiotherapy is an important factor in predicting lower recurrence and better survival. Whether the sequential addition of immunotherapy to neoadjuvant chemoradiotherapy will be beneficial to improving the pathologic complete response rate is unknown.
METHODS
Patients with pathologically confirmed thoracic esophageal squamous cell carcinoma and at clinical T1-2N1-3M0 or T3-4aN0-3M0 (stage II-IVA) according to the eighth edition of American Joint Committee on Cancer staging will be allocated to receive neoadjuvant radiotherapy (41.4 Gy with 23 fractions to planning target volume) with concurrent chemotherapy (albumin-bound paclitaxel, 100 mg/m, once weekly for five weeks; carboplatin, area under the curve of 2 mg/mL/min, once weekly for five weeks) plus tislelizumab monotherapy sequentially (200 mg every three weeks for three cycles, beginning from the first to the 14th day after the end of radiotherapy). Then, subtotal esophagectomy with two-field lymphadenectomy, including the whole mediastinum and abdomen, will be performed. The primary endpoint for this study is the pathologic complete response rate after neoadjuvant chemoradiotherapy plus tislelizumab.
DISCUSSION
The optimal timing of the combination of immunotherapy and neoadjuvant chemoradiotherapy in esophageal carcinoma is not determined. The results of this phase II trial will be helpful to clarify the safety and efficacy of the sequential addition of tislelizumab after neoadjuvant chemoradiotherapy for locally advanced resectable esophageal carcinoma.
TRIAL REGISTRATION
This study was approved on January 26, 2021 and retrospectively registered with ClinicalTrials.gov ( NCT04776590 ) on March 1, 2021.
背景
新辅助放化疗后再行手术治疗，可切除食管癌的失败率约为 34.6%-48%。新辅助放化疗后的病理完全缓解是预测复发率低和生存更好的重要因素。免疫疗法序贯加入新辅助放化疗是否有利于提高病理完全缓解率尚不清楚。
方法
根据第八版美国癌症联合委员会分期，将病理证实的胸段食管鳞癌且临床分期为 T1-2N1-3M0 或 T3-4aN0-3M0（Ⅱ-ⅣA 期）的患者分配接受新辅助放疗（计划靶区 41.4 Gy，23 次分割），同期化疗（白蛋白结合紫杉醇，100mg/m，每周一次，共五周；卡铂，曲线下面积 2mg/mL/min，每周一次，共五周），序贯替雷利珠单抗单药治疗（放疗结束后第 1 天至第 14 天，每三周 200mg，共三个周期）。然后行根治性食管大部切除术加二野淋巴结清扫术，包括整个纵隔和腹部。本研究的主要终点是新辅助放化疗加替雷利珠单抗后的病理完全缓解率。
讨论
免疫治疗与新辅助放化疗联合在食管癌中的最佳时机尚未确定。本Ⅱ期试验的结果将有助于阐明新辅助放化疗后序贯替雷利珠单抗治疗局部晚期可切除食管癌的安全性和有效性。
试验注册
本研究于 2021 年 1 月 26 日获得批准，并于 2021 年 3 月 1 日在 ClinicalTrials.gov 上进行了回顾性注册（NCT04776590）。
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