This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. It will also compare the effectiveness and safety of low-dose radiotherapy versus standard-dose radiotherapy in neoadjuvant regimens that include benmelstobart with concurrent radiochemotherapy. This research may provide more treatment options for patients with esophageal squamous cell carcinoma.
Eligible participants will be randomly assigned in a 1:1 ratio to either the benmelstobart plus radiochemotherapy group or the radiochemotherapy group. Surgery will be performed 6-8 weeks after the completion of neoadjuvant treatment, with the primary endpoint being the rate of pathological complete response (pCR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Benmelstobart: 1200 mg, i.v.gtt , d1, 22; Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week(If the number of patients achieving pCR in this group is ≥ 18 with the first 30 patients enrolled, the subsequent 20 patients will receive a reduced dose of 36 Gy in 20 fractions, 5 days per week.)
Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGLiaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
RECRUITINGZhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPathological complete response (pCR)
The ratio of patients with no residual cancer cells found in the pathological examination after treatment.
Time frame: 4 months
Major pathologic response (MPR)
The percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.
Time frame: 4 months
Overall response rate (ORR)
The proportion of patients achieved a best overall tumor response of complete response (CR) or partial response (PR).
Time frame: 4 months
Diseases control rate (DCR)
The proportion of patients achieved CR+PR+ stable disease (SD).
Time frame: 4 months
R0 resection rate
The proportion of subjects who could undergo R0 resection.
Time frame: 4 months
Disease free survival (DFS), 1y-DFS
The time from surgery to the onset of tumor recurrence or death from any cause.
Time frame: 15 months
Overall survival (OS), 1y-OS
The time from randomization to the time of death from any cause.
Time frame: 15 months
Surgical-related Indicators
Surgical Time: Defined as the duration from the start to the end of the surgery for the participant. Intraoperative Blood Loss: Defined as the amount of blood lost by the participant during the surgery. Postoperative Length of Stay: Defined as the duration from the end of surgery until the participant is discharged. Perioperative Complication Rate: Defined as the percentage of participants who experience complications during the perioperative period among all participants.
Time frame: 1 months
Neoadjuvant Treatment Completion Rate
The percentage of participants who complete neoadjuvant treatment among all participants.
Time frame: 1 months
Adverse events
The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard.
Time frame: 15 months
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