托瑞帕利单抗联合诱导化疗及后续放化疗作为晚期/转移性食管癌患者一线治疗的单臂、前瞻性、开放标签II期临床试验方案（TR-EAT）
Toripalimab in Combination With Induction Chemotherapy and Subsequent Chemoradiation as First-Line Treatment in Patients With Advanced/Metastatic Esophageal Carcinoma: Protocol for a Single-Arm, Prospective, Open-Label, Phase II Clinical Trial (TR-EAT).
作者信息
Wu Lei, Wang Yi, Li Baisen, Wan Gang, Liang Long, Li Tao, Lang Jinyi, Wang Qifeng
机构信息
Radiation Oncology Key Laboratory of Sichuan Province, Department of Radiation Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
出版信息
Front Oncol. 2022 Apr 8;12:878851. doi: 10.3389/fonc.2022.878851. eCollection 2022.
UNLABELLED
Immune checkpoint inhibitor therapy combined with chemotherapy is safe and effective in treating advanced esophageal carcinoma; however, some patients still experience tumor progression and/or metastasis. Whether the addition of radiotherapy to immunotherapy combined with chemotherapy improves the prognosis of patients with advanced/metastatic esophageal carcinoma needs to be investigated. In the present study, we developed a protocol for our clinical trial indicating that toripalimab combined with induction chemotherapy followed by chemoradiotherapy can safely prolong survival in patients with stage IV esophageal carcinoma. This open-label, single-arm, phase II trial will include patients with unresectable stage IV esophageal squamous cell carcinoma who have not received prior systemic therapy. The patients will be treated with two cycles of toripalimab (240 mg, 1 day before chemotherapy, Q3W) combined with induction chemotherapy (paclitaxel, 135-175 mg/m + carboplatin, area under the curve = 4-6, day 1, intravenous, Q3W). Thereafter, they will undergo two cycles of the aforementioned treatment with concurrent radiotherapy (30-50 Gy in 15-25 fractions), followed by toripalimab (240 mg, day 1, Q3W) for 1 year. The primary outcome measure will be progression-free survival; the secondary outcome measures will include the objective response rate, disease control rate, duration of remission, 1- and 2-year overall survival rates, safety and tolerability, and changes in health-related quality of life. The study protocol was approved by the Ethics Committee of Sichuan Cancer Hospital (SCCHEC-02-2021-021). The trial is underway in accordance with the Declaration of Helsinki.
CLINICAL TRIAL REGISTRATION
http://www.chictr.org.cn/showproj.aspx?proj=126830, identifier ChiCTR2100046715.
未标注
免疫检查点抑制剂疗法联合化疗在治疗晚期食管癌方面安全有效；然而，一些患者仍会出现肿瘤进展和/或转移。免疫疗法联合化疗时加用放疗是否能改善晚期/转移性食管癌患者的预后尚需研究。在本研究中，我们制定了一项临床试验方案，表明特瑞普利单抗联合诱导化疗后进行放化疗可安全延长IV期食管癌患者的生存期。这项开放标签、单臂、II期试验将纳入未接受过先前全身治疗的不可切除IV期食管鳞状细胞癌患者。患者将接受两个周期的特瑞普利单抗（240 mg，化疗前1天，每3周一次）联合诱导化疗（紫杉醇，135 - 175 mg/m² + 卡铂，曲线下面积 = 4 - 6，第1天，静脉注射，每3周一次）。此后，他们将接受两个周期的上述治疗并同步放疗（15 - 25次分割，30 - 50 Gy），随后接受特瑞普利单抗（240 mg，第1天，每3周一次）治疗1年。主要观察指标将是无进展生存期；次要观察指标将包括客观缓解率、疾病控制率、缓解持续时间、1年和2年总生存率、安全性和耐受性以及健康相关生活质量的变化。研究方案已获四川省肿瘤医院伦理委员会批准（SCCHEC - 02 - 2021 - 021）。该试验正在按照《赫尔辛基宣言》进行。
临床试验注册
http://www.chictr.org.cn/showproj.aspx?proj=126830，标识符ChiCTR2100046715 。
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