thymic epithelial tumors
Conditions
Interventions
Case series:Neoadjuvant therapy combined with chemotherapy (once every 2 weeks, 2-3 cycles) was performed before operation. After operation patients continued to receive 2 cycles of immunotherapy and
Sponsors
Department of Thoracic Surgery, Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with thymic epithelial tumors confirmed by needle biopsy; 2. Chest CT, PET-CT were identified as local advanced thymic epithelial tumors (masaoka-koga stage III-IVA) patients; 3. Patients without systemic metastasis (MRI, bone scan, PET-CT, liver and adrenal CT, etc.); 4. Patients over 18 years old; 5. Patients with at least one measurable tumor focus (the longest diameter measured by CT > 10 mm); 6. Patients with good function of other main organs (liver, kidney, blood system, etc.): (1) hemoglobin >= 90 g/L (can be maintained or exceeded by blood transfusion); (2) RBC count >= 2.0x10^12/L; (3) neutrophil absolute count (ANC) >= 1.0 x 10^9/L; (4) platelet count >= 100 x 10^9/L; (5) total bilirubin = 60ml / min; (8) the international standard ratio of prothrombin time (INR) <1.5R and partial thromboplastin time (APTT) <1.5 ULN in patients who have not received anticoagulant treatment. Patients receiving full dose or parenteral anticoagulant therapy can enter the clinical trial as long as the dosage of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment; 7. Patients with ECOG PS score of 0-1; 8. Patients who are expected to undergo radical surgery; 9. Patients with good lung function and tolerance to surgical treatment; 10. Pregnant women of childbearing age must conduct pregnancy test within 7 days before treatment and the result is negative; reliable contraceptive measures (such as IUD, contraceptive pill and condom) should be used within 30 days before the start and end of the test; male subjects of childbearing age should use condom for contraception within 30 days after the start and end of the test; 11. Patients willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;; 2. Participants who have received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 3. Administration of any Chinese medicine against cancer before administration of the drug; 4. Participants with cancer other than thymic epithelial tumors(excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study; 5. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 6. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial; 7. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted; 8. In the 6 months prior to enrollment, Participants had a history of active bleeding, received thrombolytic therapy or anticoagulant therapy, or were considered to have a significant tendency of gastrointestinal bleeding (such as bleeding risk of esophageal varices, locally active ulcerative lesions, etc.) or active hemoptysis; 9. Participants who have a history or is currently suffering from nephrotic syndrome; 10. Participants who are allergic to the test drug or any auxiliary materials; 11. Participants with active hepatitis B, hepatitis C or HIV; 12. The vaccine was administered within 4 weeks of the start of the trial; 13. Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial; 14. Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion; 15. Pregnant or lactating women; 16. Participants suffering from nervous system diseases or mental diseases that cannot cooperate; 17. Participated in another therapeutic clinical study; 18. Other factors that researchers think it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission;Drug safety; | — |
Countries
China
Contacts
Public ContactNan Song
Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University
Outcome results
None listed