Perioperative adebrelimab plus chemotherapy for resectable locally advanced esophageal squamous carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University Cancer Hospital
  Beijing, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

  This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886047

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

• Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

  This trial tests whether the combo of SHR-7787 and SHR-1316 can help adults with unresectable limited-stage small cell lung cancer after prior platinum-based chemo and radiation.

  Recruiting Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Jinan, Shandong · NCT07798947

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

  This trial tests a short course of radiotherapy combined with Adebrelimab and platinum chemotherapy to shrink locally advanced cervical cancer before surgery.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07731828

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.