Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous… (NCT06420908) | Clinical Trial Compass
WithdrawnNot Applicable
Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
Stopped: The primary reason for termination was difficulty in recruitment
0Started 2024-05-30
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 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
✓.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma，stage II-IVa：T1N2-3M0，T2-4bN+M0； 3.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; 4.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; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0\~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria:
✓. Blood routine examination:
✓. HB≥90g/L;
✓. ANC ≥ 1.5 × 109 / L;
✓. PLT ≥ 100 × 109 / L;
✓. Biochemical examination:
✓. ALT and AST \< 2.5×ULN;
✓. TBIL ≤ 1.5×ULN;
Exclusion criteria
✕. Previous history of esophageal cancer surgery；
✕. Higher risk of esophageal perforation or fistula；
✕
What they're measuring
1
Progression free survival (PFS)
Timeframe: evaluated in 24 months since the treatment began
. Received systemic immunosuppressive therapy within 14 days prior to the first study medicationï¼›
✕. Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function;
✕. The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
✕. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)；
✕. Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur;
✕. History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade\>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention;