At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.
This single-arm trial is designed to evaluate the efficacy and safety of concurrent immunotherapy (sintilimab) plus radiotherapy with immunonutrition support (enteral nutritional emulsion (TPF-T) followed by consolidation immunotherapy in inoperable patients with locally advanced or early stage esophageal squamous cell carcinoma , who are PD-L1 positive expression and intolerant to cCRT. The eligible patients will receive concurrent treatment consisting of total dose of 50-60 Gy in 25-30 fractions and 200 mg of sintilimab administered every three weeks, along with enteral nutritional emulsion (TPF-T) support (600-1600 ml per day according to the nutrition status evaluation). The primary outcome is 1-year progression-free survival (PFS) rate. The investigators hypothesized PD-L1 inhibitor plus radiotherapy will improve the 1-year PFS from 40% to 60%. Then, 58 patients will be needed in total. The secondary outcomes will include objective response rate (ORR), overall survival (OS), progression-free and overall survival, and incidence of adverse events. This study is approval by the National GCP Center for Anticancer Drugs, Independent Ethics Committee, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College (Study ID: 24/074-4354).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Interventions consist of 50-60 Gy in 25-30 fractions of radiotherapy.
200 mg of Sintilimab administered every three weeks concurrently with radiotherapy and after radiotherapy as consolidation therapy up to 1year.
600-1600 ml of TPF-T per day according to the nutrition status evaluation
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Department of Radiation Oncology,Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital
Fujian, Fujian, China
Department of Oncology, Affiliated Hospital, Hebei University of Engineering
Handan, Hebei, China
Department 1st of Radiation Oncology, Anyang Tumor Hospital
Anyang, Henan, China
Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University
Xinxiang, Henan, China
Department of Radiation Oncology, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Department of Radiation Oncology,Fei County People's Hospital
Feixian, Shandong, China
Department of Radiation Oncology, Affiliated hospital of Jining Medical University
Jining, Shandong, China
Taizhou hospital of Wenzhou Medical University
Taizhou, Zhejiang, China
1-year Progression-free survival rate (PFS)
Progression-free survival rate is defined the rate of progress event at 1-years after radiotherapy. Progression event is defined as event of primary tumor and regional recurrence, or distant metastasis
Time frame: From start of treatment until 1 years of follow-up.
Objective response rate
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Measured at 3 months after completion of radiotherapy
Progression-free survival
Progression-free survival is defined as the time from treatment to the event of primary tumor and regional recurrence, or distant metastasis
Time frame: Measured at months 6, 12, 18, and 24.
Overall survival rate
Live rate at months 6, 12, 18, and 24.
Time frame: Measured at months 6, 12, 18, and 24.
Overall survival
Live status at different time points.
Time frame: From start of treatment until 3 years of follow-up.
Incidence of adverse events
Adverse events are classified according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) criteria.
Time frame: Measured at months 6, 12, 18, and 24.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.