Adebrelimab plus chemotherapy before surgery for borderline-resectable esophageal squamous cell 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 phase 2 trial evaluates the safety and preliminary efficacy of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for adults with borderline resectable locally advanced esophageal squamous cell carcinoma. Participants receive 3-week cycles, with efficacy assessed after two cycles to decide on proceeding to radical surgery or alternative treatments. If resection becomes feasible, surgery is performed; if not, definitive chemoradiotherapy or first-line therapy for advanced disease may be given. Adjuvant therapy decisions are made by the MDT based on resection status and patient condition. Primary goals are to increase R0 resection rates, reduce recurrence, and improve overall survival while avoiding radiotherapy-related toxicity where possible.

Why it matters

Who can join: the full rules

Inclusion Criteria:1.Voluntarily participate in the study and sign the written informed consent form.

2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion.

4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.

7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.

8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN.

9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.

10.Fertile patients must adopt effective contraceptive measures throughout the study period.

11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol.

Exclusion Criteria:

1. Patients with cervical esophageal squamous cell carcinoma.
2. Patients with distant metastasis.
3. Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.
4. Patients with prior placement of esophageal or tracheal stents.
5. Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.
6. Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
7. Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone ≤ 10 mg/day or equivalent), or glucocorticoids administered for contrast medium allergy prophylaxis.
8. Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.
9. Known history of primary immunodeficiency.
10. Confirmed active tuberculosis.
11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
12. Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients.

14.Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension.

15.Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.

Where it's running

• No. 651 Dongfeng East Road, Guangzhou
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hong Yang, MD, PhD
• Email: yanghong@sysucc.org.cn
• Phone: 86-13560405144

Similar studies

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

• Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma

  This study tests whether giving adebrelimab with paclitaxel, carboplatin, and short-course radiotherapy before surgery helps ESCC patients.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07595770

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• 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

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.