A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurr… (NCT07112833) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
China36 participantsStarted 2025-08-10
Plain-language summary
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT or RECIST1.1 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\. Age 18-75 years old, both men and women; 2. Histopathology confirmed esophageal squamous cell carcinoma, locally advanced: T1N+M0, T2-4bNxM0; 3. The surgeon assesses that surgery is not feasible or the patient refuses surgical treatment; 4. If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 5. Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 6. Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 7. At least one measurable lesion(According to RECIST 1.1:The long diameter of the measurable lesion on CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm); 8. ECOG: 0\~1; 9. Expected survival period ≥ 12 weeks; 10. Major organ function has to meet the following certeria: (1) Blood routine examination: 1. HB≥90g/L; 2. ANC ≥ 1.5 × 109 / L; 3. PLT ≥ 100 × 109 / L; (2) Biochemical examination: a. ALT and AST \< 2.5XULN; b. TBIL ≤ 1.5XULN; c. Cr ≤ 1.5XULN; 11. Left ventricu…