Adebrelimab Neoadjuvant Treatment for Resectable ESCC
22 participantsStarted 2026-02-15
Plain-language summary
This is a prospective, phase II, exploratory clinical trial.
The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma.
The primary endpoint is pCR ( pathological complete response), evaluating the efficacy of adebrelimab in combination with nimotuzumab and neoadjuvant chemotherapy in patients with resectable esophageal squamous cell carcinoma. After the primary objective is achieved, EFS (event free survival ), R0 resection rate, MPR (major pathological response), OS (overall survival), and safety will be assessed as key secondary objectives. The study plans to enroll 22 patients with resectable esophageal squamous cell carcinoma.
The study is divided into a screening period, a treatment period, and a follow-up period. Subjects will enter the screening period after signing informed consent. Subjects who pass the screening assessment will be enrolled in the study. Eligible subjects will receive two cycles of neoadjuvant therapy with adebrelimab, nimotuzumab, nab-paclitaxel, and cisplatin. Esophagectomy will be performed after two cycles of neoadjuvant therapy (4-6 weeks after the last dose). Researchers will determine subsequent treatment based on postoperative pathology. After treatment (surgery), safety and efficacy follow-ups will commence. When a subject first experiences disease progression as assessed by the investigator according to RECIST v1.1, confirmation is required after 4-6 weeks (except for rapid or significant clinical progression). Subjects whose disease progression is not confirmed by imaging after 4-6 weeks may continue treatment if their clinical symptoms remain stable, as determined by the investigator, until imaging-confirmed disease progression occurs, or other termination criteria as specified in the protocol are met, whichever occurs first.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent to voluntarily participate in this study;
. Presence of supraclavicular lymph node metastasis;
✕. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
✕. Malnutrition with BMI \< 18.5 kg/m²; if corrected by symptomatic nutritional support prior to enrollment and approved by the principal investigator, enrollment may still be considered;
✕. History of allergy to monoclonal antibodies, any component of adebrelimab, any component of Nimotuzumab, albumin-bound paclitaxel, cisplatin, or other platinum-based drugs;
✕. Prior or current treatment with any of the following: (1) Any radiation therapy, chemotherapy, or other anti-neoplastic agents directed at the tumor; (2) Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration; Inhaled or topical steroids and corticosteroid replacement therapy at a dose \>10 mg/day of prednisone or equivalent are permitted in the absence of active autoimmune disease; (3) Received a live attenuated vaccine within 4 weeks prior to the first dose of study drug; (4) Undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of study drug;
✕. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Individuals with psoriasis or childhood asthma/allergies that have achieved complete remission and require no intervention in adulthood may be considered for inclusion; however, patients requiring medical intervention with bronchodilators are excluded;
✕. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;