Evaluating the efficacy and safety of PD-L1 (Programmed Death-L1)antibody combined with endoscopy and radiotherapy for inoperable cT1b-2 (clinical stage tumor 1b-2) esophageal squamous cell carcinoma
Previous studies have already confirm immunotherapy combine with chemotherapy can improve pathological complete response rates. Therefore, it is proposed to carry out a study of immuno-combination chemotherapy combined with endoscopic resection and synchronous radiotherapy and chemotherapy in patients with clinical stage cT1-2N0M0 (clinical stage tumor 1b-2 clinical stage nodes 0 stage metastasis 0) to evaluate the efficacy and safety
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Experimental group:Adebrelimab is an innovative PD-L1 inhibitor, monotherapy can improve pathological complete response rates with tolerable safety
Experimental group:combined with Adebrelimab(PD-L1 inhibitor),and carboplatin followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin
Experimental group:combined with Adebrelimab(PD-L1 inhibitor),and albumin-bound paclitaxel followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin
Pathological complete response of primary lesion
defined as the proportion of subjects with no residual tumor in the primary tumor site and histologically negative lymph nodes
Time frame: 14 days after endoscopic resection
Major pathological response
defined as the percentage of subjects with \<10% residual tumor in the primary tumor site
Time frame: 14 days after endoscopic resection
Overall Survival
Overall Survival
Time frame: From date of signed informed consent until the date of death from any cause, whichever came first, assessed up to 100 months
Recurrence free survival
Recurrence free survival
Time frame: From the time of complete response to the date of recurrence,assessed up to 100 months
Incidence of Adverse events
Incidence of Adverse events
Time frame: through study completion, assessed up to 50 months
Patients' quality of life
Assessment of patients' quality of life by means of quality of life score questionnaires, such as EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
Time frame: through study completion, assessed up to 50 months
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