esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group 1:Adbelizumab combined with chemoradiotherapy
Experimental group 2:Adebelizumab sequential chemoradiation
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study, signed informed consent, had good compliance, and cooperated with follow-up visits; 2. Ages 18-75, including 18 and 75, both male and female; 3. Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma with stage II-IVa clinical stage that is unresectable (including unresectable, or with contraindications or refusal to undergo surgery) (according to AJCC stage 8, the pre-treatment clinical stage is cT1N2-3M0, cT2-4bN0-3M0); 4. There are measurable and/or unmeasurable lesions that meet the definition of solid tumor response Evaluation Criteria (RECIST1.1); 5. Have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, local therapy and other investigational therapeutic drugs, etc.); 6.ECOG: 0 ~ 1 score; 7. Fresh or archived tumor tissue samples within 6 months should be provided for biomarker (such as PD-L1) analysis. The sample type is FFPE tumor tissue block or at least 5 unstained FFPE tumor tissue slices with a thickness of 3-5µm. Patients who cannot provide tissue samples meeting the above requirements should be discussed by the investigators to determine whether to enroll; 7. Fresh or archived tumor tissue samples within 6 months should be provided for biomarker (such as PD-L1) analysis. The sample type is FFPE tumor tissue block or at least 5 unstained FFPE tumor tissue slices with a thickness of 3-5µm. Patients who cannot provide tissue samples meeting the above requirements should be discussed by the investigators to determine whether to enroll; 8. Expected survival =3 months; 9. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before screening) : a. Absolute neutrophil count (ANC) =1.5×109/L; b. Platelet =100×109/L; c. Hemoglobin =9g/dL; d. Serum albumin =2.8g/dL; e. Total bilirubin =1.5×ULN, ALT, AST and/or AKP=2.5×ULN; f. Serum creatinine =1.5×ULN or creatinine clearance =60mL/min (calculated according to Cockcroft-Gault formula); g. International Standardized ratio (INR) and activated partial thromboplastin time (APTT) =1.5×ULN (for stable dose anticoagulants such as low molecular weight heparin or warfarin and INR can be screened within the intended therapeutic range of anticoagulants); 10. Fertile female subjects should undergo a urine or serum pregnancy test and prove negative within 72 hours prior to receiving the initial study drug administration, and be willing to use effective methods of contraception during the test period until 6 months after the last dose. For male subjects whose partner is a woman of reproductive age, effective contraception should be used during the trial and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. History of esophageal cancer surgery; 2. Previous history of fistula due to primary tumor infiltration; 3. High risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation; 4. Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. Patients with severe heart, lung, liver, renal insufficiency, hematopoietic system diseases, endocrine diseases, cachexia, etc., or who cannot tolerate radiotherapy or chemotherapy (including chemotherapy drug resistance) for any reason; 7. Have received or are receiving any of the following treatment: a. Anti-pd-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; b. Received any investigational drug within 4 weeks prior to the first use of the investigational drug; c. Patients requiring systemic treatment with corticosteroids (equivalent dose > 10 mg prednisone per day) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for local esophageal inflammation and prevention of allergy and nausea and vomiting. Other special cases require communication with the researcher. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses > 10mg/ day of prednisone efficacy are permitted; d. Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the investigational drug; 8. Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or childhood asthma/allergies that have healed and do not require any intervention as adults; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid replacement hormone and type 1 diabetes treated with a stable dose of insulin may be included; 9. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 10. Subjects with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 11. Severe infections (CTC AE > Class 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug requiring treatment with oral or intravenous antibiotics, except in cases of prophylactic antibiotic use; 12. Abnormal laboratory values of sodium, potassium and calcium greater than grade 1 existed within 2 weeks before randomization and could not be improved after treatment; 13. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12m-PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;DoR;cCR;safety; | — |
Countries
China
Contacts
Public ContactWang Linlin
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed