A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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 ventricular ejection fraction (LVEF) ≥50%; 12. Female subjects of childbearing age or male who undergo non-surgical sterilization must agree to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pill) for contraception during the study treatment period and within 3 months after the end of the study treatment period. For female subjects of childbearing age who undergo non-surgical sterilization, the serum HCG test must be negative within 7 days before the first administration. 13. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Disqualifiers

1. Previous history of esophageal cancer surgery; 2. Higher risk of esophageal perforation or fistula; 3. Received systemic immunosuppressive therapy within 14 days prior to the first study medication; 4. Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function; 5. 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); 6. 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); 7. Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur; 8. 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; 9. Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate.

Trial design

Treatments tested in this trial

  • Induction stage:Adebrelimab+TC;Treatment stage: TC/PF+ radiation therapy;Maintenance stage: Adebrelimab

Treatment groups

36 Participants
are divided into 1 treatment group