Operable thoracic esophageal squamous cell carcinoma
Conditions
Interventions
Test group:Neoadjuvant chemotherapy combined with immunotherapy
Operation
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years, both men and women; 2.The initial diagnosis was thoracic esophageal cancer. 3.Histological biopsy confirmed esophageal squamous cell carcinoma. 4.Referring to the 8th TNM staging system of the Union for International Cancer Control (UICC)/American Joint Committee on Cancer (AJCC), The cTNM stages were cT1-2N1-3M0 or cT3-4aN0-3M0 5.Have not previously received other oncological treatment for esophageal cancer; 6.KPS physical state =70 points; 7.The function of the vital organs meets the following requirements:(1)Blood routine examination criteria should be met(no blood components or cell growth factors are allowed to be used 2 weeks before the study begins) :Hb=100 g / L; b.ANC=1.5 x109 / L;c.PLT=100 x109 / L;(2)Liver and kidney function is normal; 8.Voluntarily participate in this experiment and sign the informed consent. 9.The investigator is judged to be able to adhere to the research protocol; 10.Screening for pregnancy tests(Women of child-bearing age )were negative ; 11.Male patients with fertility and those at risk of fertility and pregnancy.Female patients had to consent to contraception throughout the study period; 12.Subjects voluntarily participate in this study.Signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1.Previously received anti-tumor drugs or radiation therapy. 2.Patients who have had or are currently suffering from other malignant tumors within 5 years have been cured Exceptions include carcinoma in situ of the cervix, non-melanoma skin cancers, and superficial bladder tumors[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating base)Membrane)]; 3.There was a definite bleeding tendency or significant clinical significance within the first 28 days of enrollment Symptoms of bleeding, including but not limited to gastrointestinal bleeding, nasal bleeding (noIncluding epistaxis and retractile rhinorrhea), and persistent bleeding disorders or coagulopathy; 4.Those who had hematemesis or hemoptysis (defined as hematemesis or cough up) within 28 days prior to enrollment=1 teaspoon blood or small blood clots), but does not exclude blood in the sputum; 5.X-ray imaging within 28 days prior to enrollment showed the presence of a deep and large niche in the esophagus.Signs of stabbing, angulation and torsion; 6.Subjects who are known to be allergic to Cardonilizumab; 7.Received systemic immunomodulators (including but not limited to interferon and interleukin-2) within 28 days prior to enrollment; 8.Subject had any of the following severe acute comorbidities prior to enrollment:?The presence of unstable angina pectinis and/or congestive heart failure or vascular disease (e.g., aortic aneurysm or peripheral venous thrombosis requiring surgical repair) within 12 months of hospitalization or as determined by the investigator may affect the safety of the investigational drug.Evaluation of other heart damage (e.g., poorly controlled arrhythmias, myocardial infarction or ischemia);?History of abdominal fistula, gastrointestinal perforation, intraperitoneal abscess or acute gastrointestinal bleeding within 6 months;?Aggravated Chronic Obstructive Pulmonary Disease (COPD) or other respiratory condition requiring hospitalization within 28 days;?Active lung infection and/or acute bacterial or fungal infection requiring intravenous antibiotic treatment within 28 days;?Being pregnant or breastfeeding;?Grade II and above interstitial pneumonia was present at the end of radiotherapy. Or grade III or above liver and kidney function impairment, or grade IV or above hemoglobin, neutrophil cells, or platelet abnormalities that do not recover within 2 weeks after the end of radiotherapy; 9.When virological tests during the screening period show any of the following:?HBsAg positive and HBV DNA titer in peripheral blood = 1×103 copies/L;?Anti-HCV positive;?HIV positive; 10.Participated in other anti-tumor drug clinical trials within 28 days before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative objective response rate;Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;safety;survivability; | — |
Countries
China
Contacts
Public ContactKe Jiang
1277Jiefang Avenue, Jianghan District, Wuhan City, Hubei Province, China
Outcome results
None listed