Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Chemotherapy and radiotherapy plus Camrelizumab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Sign a written informed consent form before joining the group 1. Age range: 18-75 years old, both male and female are welcome; 2. Prior to treatment, MDT discussion was conducted to determine the presence of esophageal fistula or to assess a high risk of esophageal fistula; 3. Prior to treatment, MDT discussion was conducted to evaluate the potential for surgical resection of locally advanced esophageal squamous cell carcinoma; 4. No distant metastasis; 5. Willing to undergo nutritional assessment and receive gastrointestinal nutrition support therapy; 6. There are measurable and/or unmeasurable lesions that meet the definition of RECIST v1.1; 7. ECOG score: 0 to 1; 8. Expected survival period greater than 6 months; 9. The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): Normal bone marrow reserve function, neutrophil count >=1500/mm^3, platelet count >= 100000/mm3, hemoglobin >= 5.6 mmol/L (9g/dL); Normal renal function or serum creatinine = 60 ml/min Normal liver function or bilirubin <= 1.5 times ULN, ASAT&ALST <= 1.5 times ULN 10. Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum or urine HCG test within 7 days prior to enrollment in the study; And it must be during non lactation period; Non surgical sterilization or male patients of childbearing age need to agree to use a medically approved contraceptive measure with their spouse during the study treatment period and within 3 months after the end of the study treatment period. The subjects voluntarily joined this study, showed good compliance, and cooperated with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions cannot be included in this study 1. Merge tracheal fistula; 2. Previously received radiation therapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy; 3. Imaging confirms the presence of distant metastases in patients; 4. The subject has previous or concurrent malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 5. Previous PD1 or other PD-1/PD-L1 treatments cannot be included in the study; It is known that the subject has a history of allergies to macromolecular protein preparations or any PD-1 components; 6. Subjects with any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without any intervention in adulthood; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 7. The subject is currently using immunosuppressive agents, systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dose>10mg/day prednisone or other therapeutic hormones), and has continued to use them within 2 weeks prior to enrollment; 8. Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage; 9. Patients with uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 10. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 11. The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers in the stomach and duodenum, ulcerative colitis, portal hypertension, or active bleeding from unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation; 12. Previous or current severe bleeding (bleeding>30 ml within 3 months), hemoptysis (fresh blood>5 ml within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) occurring within 12 months; 13. The subject has an active infection or an unexplained fever>38.5 degrees Celsius during the screening period or before the first dose (according to the researcher's judgment, the subject can be included if the fever is caused by the tumor); 14. Having experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks prior to medication; 15. Patients with objective evidence of past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc; 16. Subjects have congenital or acquired immune deficiency, such as HIV infected persons, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 10 ?/ml; hepatitis C reference: HCV RNA >= 103/ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml (<104 copies/ml) must receive antiviral treatment during the trial period in order to be enrolled; 17. The subjects are currently participating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital
Outcome results
None listed