Perioperative adebrelimab plus chemotherapy for resectable locally advanced esophageal squamous carcinoma

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

We will test if giving adebrelimab with preoperative nab‑paclitaxel and cisplatin, followed by postoperative adebrelimab, helps people with resectable locally advanced esophageal squamous carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, adebrelimab
• Locations: 1 site (Beijing)
• Trial ID: NCT06869213 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, single-center Phase 2 study enrolling 30 patients with surgically resectable locally advanced esophageal squamous carcinoma. Participants receive neoadjuvant adebrelimab combined with nab‑paclitaxel and cisplatin before surgery, then single-agent adebrelimab as adjuvant therapy after surgery. The study will monitor safety, surgical outcomes, and anti-tumor activity including pathological response and recurrence. Results are intended to provide clinical evidence about using a PD-L1 monoclonal antibody in the perioperative setting for this cancer.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with histologically confirmed, locally advanced but surgically resectable esophageal squamous carcinoma, ECOG 0–1, no prior antitumor therapy for the cancer, and adequate organ function.

Not a fit: Patients with unresectable or metastatic disease, non-squamous histology, prior treatment for esophageal cancer, poor performance status, or contraindications to surgery, chemotherapy, or immunotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase the chance of complete tumor removal and reduce recurrence by adding immunotherapy before and after surgery.

How similar studies have performed: PD-1/PD-L1 antibodies have shown benefit in advanced esophageal cancer and neoadjuvant immunotherapy combinations have produced promising pathological responses, but perioperative use of PD-L1 antibodies in resectable esophageal squamous carcinoma is less established.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-75 years old, regardless of gender；
2. 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);
3. Presence of measurable and/or non-measurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST v1.1);
4. No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy;
5. ECOG PS 0 to 1 point;
6. No contraindication to surgery as evaluated by various organ function tests;
7. Prior to treatment, the following laboratory tests to confirm that bone marrow, liver and kidney function meet the requirements for participation in the study (requiring no blood transfusion or use of hematopoietic stimulating factors (including G-CSF, GM-CSF , EPO, and TPO, etc.) within 14 days prior to screening):

   * Hemoglobin ≥ 90 g/L;
   * White blood cell count ≥ lower limit of laboratory normal;
   * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
   * Platelet count ≥100×109/L;
   * Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN;
   * Prothrombin time ≤ 16 seconds and International Normalized Ratio (INR) ≤ 1.5 x ULN;
   * Creatinine ≤ 1.5 x ULN and Cr clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula);
8. Must understand and voluntarily sign an informed consent form.

Exclusion Criteria:

1. 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)；
2. Comorbid serious cardiac and cerebrovascular diseases:

   * 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
3. Prior history of interstitial lung disease or pneumonia requiring steroid therapy at enrollment；
4. Have a blood-borne infectious disease, including, but not limited to, hepatitis B virus carrier, hepatitis C, syphilis, or HIV;
5. Previous severe allergy to chemotherapeutic agents (paclitaxel or carboplatin) or to any of the monoclonal antibodies;
6. Active autoimmune disease requiring systemic therapy (i.e., immunomodulatory drugs, corticosteroid drugs, or immunosuppressive drugs) within the past 2 years; however, alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic and are permitted and enrollment is allowed;
7. Women during pregnancy;
8. Patients who, in the opinion of the investigator, are not suitable for participation in this study, based on a comprehensive assessment.

Where this trial is running

Beijing

• Peking University Cancer Hospital — Beijing, China (Recruiting)

Conditions Esophageal Cancer