NICE-RT study is a "safety run-in" and phase II trial evaluating the safety and efficacy of Camrelizumab combined with Nab-paclitaxel and Carboplatin and Radiotherapy in patients with resectable locally advanced esophageal squamous cell carcinoma.
Considering that immunotherapy combined with concurrent chemoradiotherapy may have unknown AEs, in order to explore the safety and tolerability of the regimen of camrelizumab combined with nab-paclitaxel and carboplatin and radiotherapy, this study set up an initial "safety run-in" phase. 10 patients will be firstly enrolled, and treatment-related adverse reactions(TRAEs)and surgical complications will be observed at the same time. If the completion rate of neoadjuvant therapy and surgery is greater than 80%, rate of 30-day major complication is less than 20%,and no death, it will continue to enroll 40 patients to explore the efficacy and safety of the regimen. If the completion rate of neoadjuvant therapy and surgery is less than 80%, the MDT will determine whether the study move forward. If treatment related death is more than 1 patients, the study will be terminated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
1. Neoadjuvant treatment period: Radiotherapy: Primary lesions and adjacent lymph nodes: The mode of involved field irradiation (IFI) is adopted, no preventive radiation is given. The total dose is 41.4Gy, 1.8Gy/23f. Distal lymph nodes ≥ 5cm away from the primary lesion: low-dose radiotherapy with a total dose of 4Gy, 0.5Gy/8f, Day1 to Day4, Day22 to Day25. Chemotherapy: Carboplatin(AUC=2), Nab-paclitaxel(80mg/m2), Day1/8/15/22/29. Immunotherapy: Camrelizumab(200mg, Day5, Day26). 2. Perioperative period: Undergo surgery within 4-6 weeks after neoadjuvant therapy 3. Adjuvant treatment period: Camrelizumab: (200mg, Q3W),continued for up to 1 years,until PD or intolerable toxicity.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Safety(The rates of grade 3 and higher-grade treatment-related adverse events)
Incidence of adverse events using CTCAE 4.03;grade 3 treatment-related adverse events and higher-grade adverse event will be reported
Time frame: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose
pCR
pathological complete response (pCR) is defined as disappearance of all invasive cancer after completion of neoadjuvant chemotherapy
Time frame: 12 months
MPR
major pathologic response (MPR) is defined as residual viable tumor of less than or equal to 10%
Time frame: 12 months
ORR
objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1
Time frame: 12 months
EFS
event-free survival (EFS) is defined as the time after treatment that a group of people in a clinical trial has not had cancer come back or get worse
Time frame: 12 months
OS
overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence
Time frame: 12 months
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