Eesophageal Cancer
Conditions
Interventions
Case series:Camrelizumab for maintenance treatment of locally advanced esophageal squamous cell carcinoma after concurrent radiotherapy and chemotherapy
Sponsors
Huai'an first people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who signed the written informed consent before joining the group; 2. Patients aged 18-70 years, both male and female; 3. Patients with primary esophageal squamous cell carcinoma confirmed by histology, locally advanced esophageal cancer confirmed by pathology and imaging, stage t3-4n0m0, t1-4n + M0, stage II - IVa, AJCC 2017 clinical stage of esophageal squamous cell carcinoma; 4. Patients with measurable and evaluable lesions in accordance with RECIST v1.1; 5. Patients with ECoG score of 0-1; 6. Patients whose expected survival time is more than 6 months; 7. Patients whose functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) 8. In patients with normal bone marrow reserve function, neutrophils >=1500/mm3, 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 ULN, ASAT & alst <=1.5 ULN; 9. Patients with non-surgical sterilization or childbearing age women were required to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; the number of non-surgical sterilization women of childbearing age before enrollment was 7 Within days, serum or urine HCG test must be negative; and it must be non lactation period; male patients with non-surgical sterilization or child-bearing age need to agree to use a medically recognized contraceptive method with their spouse during the study treatment period and within 3 months after the end of the study treatment period; 10. The subjects volunteered to participate in the study, with good compliance, safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy; 2. Patients with distant metastasis confirmed by imaging; 3. The subjects suffered from other malignant tumors (except for the cured skin basal cell carcinoma and cervical carcinoma in situ); 4. Patients who had previously received shr-1210 or other PD-1 / PD-L1 treatments and could not be included in the study; the subjects were known to have been allergic to macromolecular protein preparations or any ingredients of shr-1210; 5. Patients with any active autoimmune disease or history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and no need for any treatment in adulthood Intervention can be included; asthma patients who need bronchodilator for medical intervention cannot be included; 6. The subjects were using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisone or other effective hormones), and continued to use them within 2 weeks before enrollment; 7. Patients with ascites or pleural effusion with clinical symptoms requiring therapeutic puncture or drainage; 8. Patients with cardiac symptoms or diseases that are not well controlled, such as: (1) NYHA grade 2 and above heart failure (2) Unstable angina pectoris (3) Myocardial infarction occurred within 1 year (4) Patients with clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; 9. Patients with abnormal coagulation function (PT > 16S, APTT > 43S, TT > 21s, FBG > 2G / L) had bleeding tendency or were receiving thrombolytic or anticoagulant therapy; 10. At present (within 3 months), the patient has gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, etc., or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by researchers; 11. Patients with previous or current severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (fresh blood > 5 ml within 4 weeks), or thromboembolism events (including stroke events and / or transient ischemic attacks) within 12 months; 12. The subjects had active infection or fever of unknown origin occurred during screening period and before the first administration of the drug > 38.5 degrees (according to the judgment of the researcher, the fever caused by tumor can be included in the study group); 13. Study the patients who had abdominal fistula, gastrointestinal perforation or abdominal abscess less than 4 weeks before medication; 14. Patients with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; 15. Subjects with congenital or acquired immune deficiency, such as HIV infection 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, HBV DNA < 2000 IU / ml (< 104 copies / ml), must receive antiviral treatment at the same time during the trial; 16. Sub
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Contacts
Public ContactLuo Honglei
Huai'an First People's Hospital
Outcome results
None listed