Esophageal cancer
Conditions
Interventions
Experimental group:Neoadjuvant radiotherapy combined with candenizumab immunotherapy
Experimental expansion group:Neoadjuvant radiotherapy combined with candenizumab immunotherapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 73 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~73 years old, male or female; 2. Pathologically confirmed resectable thoracic esophageal squamous cell carcinoma (cT1b-cT2 N or cT3-cT4a, any N); 3. At least one measurable lesion (according to the requirements of RECIST version 1.1, the length diameter of spiral CT scan of measurable esophageal lesion is >=10 mm, the short diameter of CT scan of lymph node lesion is >=15 mm, and the thickness of the scan layer is not more than 5 mm; and have not received local treatment), and the measurable lesion is suitable for surgery; 4. Expected survival >= 6 months; 5. ECOG score 0-1; 6. The function of major organs is good, that is, the relevant examination indicators meet the following requirements within 1 week before enrollment: blood routine examination: a. Hemoglobin content (HB) >= 90g/L (no blood transfusion within 28 days); b. Absolute neutrophil count (ANC) >=1.5×10^9/L; c. Platelet count (PLT) >= 100×10^9/L; Biochemical Tests: a. Serum total bilirubin (TBIL) = 50%; 8. Women of childbearing age must have a negative pregnancy test (blood/urine) result within 1 week before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; For males, should be surgically sterile or agree to use an appropriate method of contraception during the observation period and for 3 months after the last administration of study drug; 9. No prior anti-tumor therapy, including surgery, chemotherapy, radiotherapy and targeted therapy; 10. Subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up;
Exclusion criteria
Exclusion criteria: 1. Inability to tolerate digestive endoscopic biopsy; 2. Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, positive fecal occult blood); History of gastrointestinal bleeding within 6 months; 3. Previous active malignancy within 5 years prior to study entry. Exceptions are basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally and have been cured; 4. Received the following treatments or medications prior to the first dose of study treatment: a. Major surgery within 28 days prior to the first dose of study drug treatment (tissue biopsy required for diagnosis is permitted); b. Live attenuated vaccine within 28 days prior to the first dose of study drug treatment or planned administration during the study and within 60 days after the end of study drug treatment; c. Receiving anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days prior to the first dose of study drug therapy; 5. Presence of any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled by hormone replacement therapy alone can be included]; Subjects with skin conditions that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes mellitus, or asthma that has been in complete remission in childhood, without any intervention after adulthood, may be included; Patients with asthma who require medical intervention with bronchodilators cannot be included); 6. Pregnant or lactating women; 7. Within 6 months prior to study entry, the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Systemic antibiotic use within 4 weeks prior to the first dose for = 7 days, or unexplained fever > 38.5°C during the screening period/before the first dose (as judged by the investigator, fever caused by tumor can be enrolled); 9. Central nervous system metastases have occurred; 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as a positive test result for hepatitis B virus surface antigen [HBsAg], HBV-DNA = 500 IU/ml and abnormal liver function; Hepatitis C, defined as hepatitis C antibody [HCV-Ab] positivity, HCV-RNA above the lower limit of detection of the analytical method, and abnormal liver function) or co-infection with hepatitis B and C; 12. Participated in any other drug clinical study within 4 weeks before the first dose; 13. Have a clear history of neurological or psychiatric disorders, including epilepsy and dementia; Known history of psychotropic substance abuse, alcoholism, or drug abuse; 14. Known hypersensitivity to the study drug or any of its excipients; or have had a severe allergic reaction to other monoclonal antibodies; 15. Patients who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical completion rate;Objective response rate;Safety indicators;Overall survival;R0 resection rate;Surgical complications;Disease free survival;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactBaosheng Li
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed