About this trial
This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 to 75 years old, no limit to male or female;
Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);
Have measurable lesions and meet RECIST v1.1) standards;
Have not received any anti-tumor systemic treatment for esophageal cancer in the past;
Disqualifiers
Patients with locked lymph node metastasis;
Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled;
Suffering from bleeding disorders or a history of bleeding disorders;
Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time;
Trial design
Single group
Treatments tested in this trial
Adebrelimab
Drugadebrelimab, IV
albumin paclitaxel
Drugalbumin paclitaxel, iv
Nedaplatin
DrugNedaplatin,IV
Treatment groups
Trial outcomes
Primary outcomes
pathological complete remission rate
After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0)
Secondary outcomes
R0 resection rate
The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope
Main pathological remission
After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10)
objective response rate
The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR).
Disease-free survival
It was calculated from the time of first administration of study drug until disease progression or death.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: