A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.

Eligibility criteria

Qualifiers

Aged 18-75 years old, regardless of gender;

Surgically resectable locally advanced squamous cell carcinoma of the esophagus confirmed by histology or cytology (pre-treatment clinical stage cT1b-cT2, N+ or cT3-cT4a, ANY N according to the 8th edition of AJCC staging);

Presence of measurable and/or non-measurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST v1.1);

No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy;

Disqualifiers

malignant tumors other than esophageal cancer within 5 years prior to enrollment (cured limited tumors are not excluded, including cervical carcinoma in situ, basal cell carcinoma of the skin, and carcinoma in situ of the prostate gland; patients with prostate cancer who received hormone therapy and obtained DFS for more than 5 years are not excluded);

Congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident of New York Heart Association (NYHA) class II or higher within 12 months prior to enrollment.

Medication-uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) (based on the average of ≥2 measurements)

Previous hypertensive crisis or hypertensive encephalopathy

Trial design

Treatments tested in this trial

  • Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin

Treatment groups

30 Participants
are divided into 1 treatment group