This trial aims to assess efficacy and safety of immunotherapy combined with chemoradiotherapy for first-line treatment of esophageal squamous cell carcinoma.
Esophageal squamous cell carcinoma is a highly aggressive malignancy, with squamous cell carcinoma accounting for over 90% of esophageal cancer cases in China. According to the American Cancer Society, the 5-year survival rates vary among patients at different stages of esophageal cancer: approximately 50% for early and mid-stage cases, around 26% for locally advanced cases, and only 5% for those with distant metastasis.In recent years, immunotherapy combined with chemotherapy has emerged as the first-line standard treatment for advanced esophageal cancer, and several phase III trials of immunotherapy combined with radiotherapy are currently underway for locally advanced esophageal cancer. Despite being a novel treatment strategy for patients with locally advanced esophageal cancer, there remains a lack of sufficient evidence-based medical data supporting the use of immunotherapy combined with chemoradiotherapy.In recent years, immunotherapy combined with chemotherapy has emerged as the first-line standard treatment for advanced esophageal cancer, and several phase III trials of immunotherapy combined with radiotherapy are currently underway for locally advanced esophageal cancer. Despite being a novel treatment strategy for patients with locally advanced esophageal cancer, there remains a lack of sufficient evidence-based medical data supporting the use of immunotherapy combined with chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Immunotherapy: intravenously, every 3 weeks for at least 6 months, or until progression, intolerance, or spontaneous withdrawal of the patient.
TP:albumin-bound paclitaxel 110-130mg/m2,d1,d8;cis-platinum 60-75mg/m2,d1 Q3W
Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Assessment of objective remission rate (ORR) in esophageal squamous cell carcinoma treated with immunotherapy combined with chemoradiotherapy
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).
Time frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Time frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of overall survival (OS) in esophageal squamous cell carcinoma
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). OS is defined as the time from the start of enrollment to death from any cause.
Time frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of progression-free survival (PFS) in esophageal squamous cell carcinoma
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of disease control rate (DCR) in esophageal squamous cell carcinoma
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD).
Time frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months