Thymic carcinoma
Conditions
Interventions
experimental group(single arm):Toripalimab combined with paclitaxel and carboplatin
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this trial: 1. Male or female >= 18 years of age. 2. Patients with pathologically confirmed Masaoka stage III / IV or progression/recurrence of thymic cancinoma after local treatment, and did not receive any systemic therapy. 3. At least one measurable disease based on RECIST 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy of at least 12 weeks. 5. No autoimmune diseases. 6. The functional level of the main organs must meet the following requirements (No blood transfusion, and no use of leukocyte-elevating and platelet-elevating drugs within 2 weeks before screening and 7 days before the first medication of the study drugs): Neutrophil (ANC) >= 1.5 x 10^9/L; platelet count (PLT) >= 100 x 10^9; hemoglobin(Hb) >= 90g/L. Coagulation: INR and APTT 1+, 24-hour urine protein should be collected for determination, and the total amount should be = 50%; normal cardiac function, i.e. ECG is normal or abnormal without clinical significance; echocardiography showed that left ventricular ejection fraction (LVEF) was greater than 50%. The hypertension is well controlled. Thyroid function: FT3, FT4 and TSH were normal or abnormal without clinical significance. 7. No systemic therapy for at least 4 weeks prior to study enrollment. 8. Patients with treated brain metastases are eligible if they are asymptomatic without steroid therapy and have not progressed after local therapy. 9. For fertile women, use high-efficiency contraceptive measures at least one month before screening, and agree to use such contraceptive measures during the study period and after of ; for fertile men, use condoms or other measures to ensure the effectiveness of sexual partner contraception. 10. Volunteer to join the study, sign the informed consent form, have good compliance to treatment and follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this trial: 1. Previously received any systemic anti-tumor therapy for locally advanced or metastatic thymic carcinoma, including systemic chemotherapy, immunotherapy, biological therapy, etc. 2. Patients who had undergone surgery before the treatment with the study drug, except for minor surgery (such as tooth extraction, etc.) that does not affect the study participation in the judgment of the investigator; or patients who are scheduled to undergo major surgery during the study period. 3. Concurrent other malignancy (except non-melanoma skin cancer and the following carcinomas in situ: carcinoma in situ of the bladder, carcinoma in situ of the stomach, carcinoma in situ of the colon, carcinoma in situ of the endometrium, carcinoma in situ/dysplasia of the cervix, carcinoma in situ of the melanoma, or carcinoma in situ of the breast), unless complete remission had been achieved at least 2 years prior to study enrollment and no other treatment was required during the study. 4. Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin and other treatments before the first dose of study drug. 5. Patients with known history of allergy to the drug components of this protocol. 6. Patients with brain metastases accompanied by symptoms or with symptom controled for less than 1 month. 7. History of immunodeficiency, including HIV infection, or other acquired, congenital immunodeficiency disease, or organ transplantation. 8. Presence of third space fluid collection (such as pleural effusion and ascites) that cannot be controlled by drainage or other methods. 9. Female subjects who are pregnant or lactating, or fertile subjects who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after study drug administration. 10. Have serious concomitant disease or other concurrent illness that would interfere with planned treatment or any other condition unsuitable for participation in this study, such as active hepatitis B, pulmonary infection requiring treatment. 11. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 12. Patients who have participated less than 4 weeks or are participating in other drug/therapy clinical trials before the first dose of study drug. 13. Patients who have a history of psychotropic drugs abuse and cannot quit or have a history of mental disorders. 14. Patients who have taken within 14 days prior to the first dose or who require concomitant use of the following medications during treatment: strong inhibitors or strong inducers of CYP3A4; warfarin or any other coumarin-derivative anticoagulant. 15. Patients with any evidence or history of bleeding diatheses regardless of severity; patients with any bleeding or bleeding event=CTCAE grade 3 before the first dose; or patients with unhealed wounds, ulcers, or fractures. 16. Have any uncontrolled clinical problem including, but not limited to: Persistent or active (serious) infection; Hypertension poorly controlled on medication (blood pressure persistently greater than 150/90 mmHg); Poorly controlled diabetes; Cardiac disease (Class III/IV congestive heart failure as defined by the New York Heart Association or heart block ); History or suspicion of any active autoimmune disease, or history of autoimmune disease or syndrome requir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission (DOR);Objective response rate (ORR);Disease control rate (DCR);Overall survival (OS);Time to first remission (TTR); | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed