Abstract 1501TiP
Background
Components of the tumour microenvironment may promote malignant transformation, support tumour growth and invasion, and promote immune evasion. Study of the tumour immune microenvironment can help to understand tumour growth, metastasis, and invasion more comprehensively. However, differences in the tumour microenvironment before and after chemotherapy, chemo-radiotherapy and immunotherapy treatment are under investigated. Here, we will take specimens of tissue and blood before and after surgery in oesophageal squamous cell carcinoma patients and measure the factors related to host immunity. The relationship between immuno-factors and clinical data, including patient characteristics, pathological treatment efficacy and long-term survival were further evaluated.
Trial design
Oesophageal squamous cell carcinoma patients (ESCC pts, n = 15) who were previously untreated, stage b-Ⅲ diagnosed histologically or cytologically, and evaluated to be operable or potentially operable are allocated to three cohorts according to pts’ preference. All pts receive neoadjuvant treatment for 6 weeks before surgery, and receive surgery at 2-4 weeks after completing neoadjuvant treatment. Cohort 1, 2 and 3 receive neoadjuvant chemotherapy, concurrent radio-chemotherapy and immunotherapy combined with radiotherapy, respectively. 200mg camrelizumab is administered as immunotherapy for two weeks per cycle (Q2W), for 3 cycles. Carboplatin combined with paclitaxel is administered as chemotherapy for three weeks per cycle (Q3W), 2 cycles. Radiotherapy dose is 44.1 Gy/21 f/2.1 Gy daily, 5 days a week. Serial CT and FDG PET/CT are used to measure response and exclude progression in the neoadjuvant phase, and to monitor for recurrence during post treatment phases. Before the neoadjuvant therapy and after surgery, the tissue and blood specimens of ESCC pts are collected and analysed by flow cytometry and ELISA. The primary endpoint is the complete pathological response rate and the rate of down-staging. Secondary endpoints include RECIST response, overall survival (OS), relapse free survival (RFS) metabolic response, safety/tolerability, surgical outcomes, quality of life, as well as biomarker analysis.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.