esophageal squamous carcinoma
Conditions
Interventions
Test Group:Camrelizumab: Administer 200mg on the first day of each cycle by intravenous infusion, lasting approximately 30 to 60 minutes. Thalidomide: Take orally, 4 tablets per dose (25 mg per tablet
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, both male and female are eligible; 2. Primary esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Locally advanced, TNM stage II-IVA (AJCC 8th edition), unable or unwilling to undergo surgical resection; 4. No previous PD-1/PD-L1 treatment; 5. Received concurrent chemoradiotherapy based on platinum/fluorouracil (>= 2 cycles) and no disease progression; 6. Received the first study treatment within 1 - 42 days after the last radiotherapy; 7. ECOG score: 0 - 1; 8. Expected survival period > 3 months; 9. The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days): hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5 × 10^9/L; platelet count >= 100 × 10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); echocardiography of the heart: left ventricular ejection fraction (LVEF) >= 50%. 10. Pregnant women of childbearing age must undergo a serum pregnancy test 7 days before the first medication and the result must be negative. Male participants of pregnant women subjects and their partners must agree to use effective contraception methods during the study and within 180 days after the last administration of the study drug. 11. Participants sign the informed consent form, voluntarily join this study, have good compliance, and cooperate with safety and survival period follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with distant metastasis confirmed by imaging; 2. Previously or concurrently suffering from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Known to be allergic to the study drug or its excipients; 4. Currently (within 3 months) having esophageal varices, active ulcers in the stomach and duodenum, ulcerative colitis, portal hypertension, or other digestive tract diseases with active bleeding, or conditions that the investigator deems likely to cause digestive tract bleeding or perforation; 5. Less than 4 weeks prior to the first administration having had abdominal fistula, gastrointestinal perforation or abdominal abscess; 6. Subjects with objective evidence of past and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 7. Having active infection or having an unexplained fever > 38.5 degrees Celsius (as judged by the investigator, the fever caused by the tumor of the subject can be included); 8. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg > 2g/L), having a bleeding tendency or undergoing thrombolytic or anticoagulant treatment; 9. Previously or currently having severe bleeding (more than 30 ml within 3 months), hemoptysis (more than 5 ml of fresh blood within 4 weeks), or thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks); 10. Having any active autoimmune disease or a history of autoimmune disease (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or having completely resolved childhood asthma can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 11. Subjects with congenital or acquired immune deficiency, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, reference for hepatitis B: HBV DNA >= 104/ml; reference for hepatitis C: HCV RNA = 10³/ml); chronic hepatitis B virus carriers, HBV DNA 10mg/day prednisone or other equivalent efficacy hormones), and still using the treatment within 2 weeks before enrollment; 13. Having clinical symptoms of ascites or pleural effusion that require therapeutic puncture or drainage; 14. Having poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 15. Subjects participating in other clinical studies or less than 1 month after the end of the previous clinical study; subjects may receive other systemic anti-tumor treatments during the study; 16. Less than 4 weeks before the study medication or possibly during the study period having received live vaccines; 17. As judged by the investigator, the subject has other factors that may cause this study to be prematurely terminated, such as, other serious d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year progression-free survival rate ;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease Control Rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactJundong Zhou
Suzhou Municipal Hospital
Outcome results
None listed