esophageal cancer
Conditions
Interventions
Experimental group:Chemotherapy: The preferred option is to combine albumin paclitaxel with platinum, Or combined with cisplatin or carboplatin
Immunization: Before chemotherapy on the first day of each cycle, intravenous infusion of 1200mg of Adelbolizumab, Q3W
Radiation therapy: using radiation therapy for the affected field of the recurrent site
Three dimensional conformal or intensity modulated radiotherapy technology, 1.8Gy/QD/45Gy, must be accompanied by chemotherapy and radiation therapy
During the maintenance treatment phase, subjects received maintenance treatment with adelbizumab every 3 weeks. Until disease progression, intolerable toxicity, or patient death occurs.
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old, fully understand and agree to the content and risks of this clinical trial, sign informed consent; 2) Pathologically diagnosed esophageal squamous cell carcinoma, after preliminary treatment (surgery/radiotherapy/chemotherapy/systemic therapy) Local recurrence occurs, which is suitable for the synchronous radiotherapy and chemotherapy designed in this study. If the patient's early treatment package,Including radiotherapy, at least 8 months have passed since the end of the last radiotherapy at the time of enrollment; 3) Can obtain tumor samples from patients at least once; 4) The expected survival period is more than 3 months; 5) The Eastern Cancer Collaborative Group (ECOG) has a physical fitness score of 0 or 1; 6) Researchers have confirmed the presence of at least one measurable lesion according to the RECIST 1.1 standard; 7) Pulmonary function measurement shows FEV1>1L; 8) CT or PET/CT confirmation of no severe interstitial lung disease before treatment; 9) For female participants of childbearing age, they should receive the first study drug administration (cycle 1), Urine or serum pregnancy test negative within 3 days prior to the first day. If urine pregnancy test If the test result cannot be confirmed as negative, a blood pregnancy test is required; 10) Good hematopoietic function, defined as an absolute neutrophil count = 1.5 × 109/L, low blood volume Board count = 100 × 109/L, hemoglobin = 90g/L [No blood transfusion or erythropoiesis within 7 days] EPO dependence; 11) Good liver function is defined as a total bilirubin level =1.5 times the upper limit of normal (ULN); No Patients with liver metastasis have levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 Double ULN; 12) Good renal function is defined as serum creatinine = 1.5 times ULN or calculated creatinine clearance rate=60 ml/min (Cockcroft Fault formula); Urinary routine examination shows negative urine protein or urine protein is less than 2+, Or 24-hour urine protein quantification<1g; 13) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN;If the subject is receiving anticoagulant treatment, as long as the PT is within the intended range of use of the anticoagulant drug; 14) The myocardial enzyme spectrum is within the normal range.
Exclusion criteria
Exclusion criteria: 1) Breastfeeding or pregnant women; 2) According to the doctor's assessment, ECOG score = 2 or intolerable due to severe symptoms, risk of esophageal fistula, etc. The synchronous radiotherapy and chemotherapy designed by this research institute may not comply with the design of this study due to other circumstances; 3) Severe radiation related toxic reactions have occurred during radiotherapy or chemotherapy prior to enrollment; 4) Patients with extensive metastasis who are not suitable for local treatment; 5) Severe heart, lung, liver, and kidney dysfunction, hematopoietic system diseases, immune system diseases Patients with cachexia and other intolerable conditions to radiotherapy and chemotherapy; 6) Currently undergoing other clinical trials; 7) Active infection, active pulmonary tuberculosis infection, previous active pulmonary tuberculosis infection, hepatitis B Surface antigen (HBsAg), hepatitis C antibody (HCV Ab), acquired immunodeficiency syndrome antibody Individuals who are positive for Anti HIV and TP Ab antibodies, and meet any of these criteria; 8)Merge patients with other tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS evaluated by researchers;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR evaluated by researchers;Overall survival;DoR evaluated by researchers;DCR evaluated by researchers;PFS rates at 6 months and 1 year;OS rates at 1 and 2 years;Adverse events (AE) and serious adverse events (SAE) evaluated based on CTCAE 5.0 Birth rate and severity, as well as abnormal laboratory test indicators;; | — |
Countries
China
Contacts
Public ContactWei Huang
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed